Anti-TNF Agents In Inflammatory Bowel Disease Linked to Small Increased Risk of Lymphoma

MedicalResearch.com Interview with:
ANSM
Rosemary Dray-Spira, MD, PhD
Department of Epidemiology
French National Agency for Medicines and Health Products Safety (ANSM)
Saint-Denis, France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Anti-tumor necrosis factor (anti-TNF) agents are increasingly used for the management of inflammatory bowel diseases (IBD), either alone or in combination with thiopurines. Their clinical benefits have been largely assessed, however they may expose to potentially serious adverse effects. While an increased risk of lymphoma has been established with thiopurines, up to now such a risk of lymphoma remained uncertain with anti-TNF agents.

In this study based upon a large, nationwide cohort of 189,289 patients with IBD, the use of anti-TNF agents alone was found associated with a 2 to 3 fold increase in the risk of lymphoma, similarly to thiopurines alone. In addition, the combination of these two treatments was associated with a 6 fold increase in the risk of lymphoma, ie a higher risk than with each treatment used alone. Although these differences are statistically significant, the risk of lymphoma among patients exposed to anti-TNF agents is less than 1 case per 1000 person-years.

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Irritable Bowel Syndrome with Constipation Patients Frustrated With Limited Treatment Options

MedicalResearch.com Interview with:

Eamonn M.M. Quigley, M.D. Director, Lynda K. and David M. Underwood Center for Digestive Disorders Houston Methodist Hospital

Dr. Quigley

Eamonn M.M. Quigley, M.D.
Director, Lynda K. and David M. Underwood Center for Digestive Disorders
Houston Methodist Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The BURDEN IBS-C (Better Understanding and Recognition of the Disconnects, Experiences, and Needs of Patients with Irritable Bowel Syndrome with Constipation) Study was designed to develop a better understanding of the experiences and attitudes associated with IBS-C.

This study consisted of more than 1,300 individuals who met IBS-C criteria (mean age 46 years; 73 percent of respondents were female) and completed the author-developed, IRB-approved online questionnaire. The study also evaluated, through an approximately 45-minute long questionnaire, more than 325 healthcare providers who treat patients with IBS-C.

Notably, the study found many patients experienced stress, lost productivity and described a feeling of frustration with their condition. HCPs recognize this frustration, yet underestimate how many patients have “accepted” their condition. Both patients and healthcare providers (HCPs) also noted a lack of satisfaction in currently available prescription treatments for IBS-C.

Detailed findings can be found here.

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PPIs for Reflux Linked To Increased Risk of Chronic Kidney Disease

MedicalResearch.com Interview with:
Charat Thongprayoon, MD

Bassett Medical Center
Cooperstown, NY 13326

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We conducted a meta-analysis including 5 observational studies with 536,902 patients to assess the risks of chronic kidney disease (CKD) and/or end-stage kidney disease (ESRD) in patients who are taking proton pump inhibitors (PPIs) and/or H2 receptor antagonists (H2RAs).

We found a statistically significant association between the use of PPI and 1.3-fold increased risk of CKD or ESRD development. Compared with H2Ras, the use of proton pump inhibitors was significantly associated with 1.3-fold higher risk for CKD development.

Conversely, there was no significant association between the use of H2RAs and chronic kidney disease.

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FDgard® Study Demonstrates Rapid Relief of Functional Dyspepsia Symptoms

MedicalResearch.com Interview with:

William D. Chey

Dr. Chey

William D. Chey, M.D., F.A.C.G.
Timothy T. Nostrant Professor of Gastroenterology & Nutrition
Director, Digestive Disorders Nutrition & Lifestyle Program
Michigan Medicine
Ann Arbor, Michigan 

MedicalResearch.com: What is the background for this study?

Response: Functional Dyspepsia (FD) has been characterized as recurring indigestion with no known organic cause and is an area of high unmet medical need. This medical condition, which is non-life threatening, can have a significant impact on an individual’s quality of life. It remains poorly recognized and presents a significant management challenge for providers and patients.

Gastrointestinal symptoms can include epigastric pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating and belching.

Currently, there are no FDA-approved drugs for FD. Off-label medications are used to treat the condition and patient dissatisfaction remains high.[1]

In a real-world, observational study, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), we analyzed information on the frequency of FD symptoms, daily consumption of capsules, onset of action, improvement in FD symptoms, quality of life and patient satisfaction among 600 patients who took FDgard®, a nonprescription medical food specially formulated for the dietary management of FD.

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Prebiotin™ Fiber Supplement Tested in NIH/NIDDK Pilot Study In End-Stage Kidney Disease Patients

MedicalResearch.com Interview with:

Ron Walborn Jr. Prebiotin CEO

Ron Walborn Jr.

Ron Walborn Jr.
Prebiotin CEO 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The product Prebiotin™ Prebiotic Fiber was brought to market in 2007 by Dr. Frank Jackson, a gastroenterologist out of Harrisburg, PA. He found through 40 years of experience with his patients that a variety of digestive issues benefitted from daily supplementation with a soluble prebiotic fiber, specifically, oligofructose-enriched inulin (OEI) derived from chicory root.

In the late summer of 2012, Prebiotin caught the attention of Dr. Dominic Raj at the Internal Medicine Department of George Washington University. Dr. Raj’s laboratory showed that patients with kidney disease may have a higher level of release of endotoxins like p-Cresol sulfate and indole from the bacteria in the gut, which can move into the bloodstream and promote inflammation.

This early work was the basis of a successful grant application. Researchers were interested in investigating the therapeutic potential of altering the composition and/or function of the gut microbiome in this patient population, based on the understanding that by building up the levels of healthy bacteria in the gut, undesirable bacteria is eventually crowded out, thereby reducing the release of harmful endotoxins into the system.

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With Increasing Westernization, Inflammatory Bowel Disease Becoming a Global Health Issue

MedicalResearch.com Interview with:

Gilaad Kaplan, MD, MPH, FRCPC Associate Professor  CIHR New Investigator & AI-HS Population Health Investigator Co-Director, Environmental Health Research Group Snyder Institute for Chronic Diseases & Institute of Public Health Departments of Medicine & Community Health Sciences University of Calgary

Dr. Kaplan

Gilaad Kaplan, MD, MPH, FRCPC
Associate Professor
CIHR New Investigator & AI-HS Population Health Investigator
Co-Director, Environmental Health Research Group
Snyder Institute for Chronic Diseases & Institute of Public Health
Departments of Medicine & Community Health Sciences
University of Calgary

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The aim of the study was to provide a global perspective on the epidemiology of the inflammatory bowel diseases in the 21st century.

During the 20th century IBD was considered a disease of the Western world. At the turn of the 21st century, IBD has become a global disease with accelerating number of cases in the developing world as it transition towards a westernized society.

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Gut Microbiome of Health Very Old Similar To Younger Adults

MedicalResearch.com Interview with:
Greg Gloor, PhD
Principal investigator
Professor at Western’s Schulich School of Medicine & Dentistry and
Scientist at Lawson Health Research Institute.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We sampled the bacteria in the gut (stool) in over 1000 members of a super healthy population in China across the age ranges of 3 to over 100. Exclusion criteria included a history of genetic or chronic disease (intergenerational in the case of people younger than 30), no smoking, drinking or drug use (including no prescription drugs).

Our goal was to identify what, if any changes in the makeup of the gut microbiota occurred in this population so that we could define “what is associated with health”.

We found three things.

  • First, that the expected differences between the very young and everyone else were found in this population. This indicates that we could observe the standards signatures of a maturing gut microbiota.
  • Second, that the gut microbiota of very healthy very elderly group (over 95 yo) was very similar to that of any very healthy person over the age of 30.
  • Third, we found that the gut microbiota of 20yo people (in three distinct groups) was different from all other age groups. The reason for the differences observed in the 20 yo groups from all the others is unknown, but is not methodological in origin.

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Peppermint Oil Based IBgard® Found Efficacious In Some Patients With Irritable Bowel Syndrome with Mixed Bowel Habits

MedicalResearch.com Interview with:

Brooks D. Cash, M.D., A.G.A.F., F.A.C.G., F.A.S.G.E. Professor of Medicine and Chief of the USA Gastroenterology Division Director, Motility and Physiology Service University of South Alabama Mobile, Alabama

Dr. Cash

Brooks D. Cash, M.D., A.G.A.F., F.A.C.G., F.A.S.G.E.
Professor of Medicine and
Chief of the USA Gastroenterology Division
Director, Motility and Physiology Service
University of South Alabama
Mobile, Alabama 

MedicalResearch.com: What is the background for this study?

Response: Irritable Bowel Syndrome (IBS) among patients with IBS-M (mixed diarrhea and constipation) is a challenging and difficult to diagnose and treat sub-type of IBS. Patients with IBS-M represent a dissatisfied group of IBS patients due to the lack of proven therapies. It is an area of high unmet medical need.

Among adult patients with IBS, a sizeable proportion suffers from IBS-M with prevalence rates estimated to be between 44 to 66 percent of IBS sufferers[1],[2],[3]. IBS-M patients carry a heavy burden, characterized by bouts of constipation interrupted by diarrhea and vice versa. Physicians find IBS-M challenging to manage because of the difficulty in avoiding ‘overshoots’ when diarrhea management can turn into constipation and vice versa.[4]  Continue reading

Appendicitis May Be More Common After Colonoscopy

MedicalResearch.com Interview with:

Marc D. Basson, MD, PhD, MBA Professor of Surgery, Pathology, and Biomedical Science Senior Associate Dean for Medicine and Research University of North Dakota School of Medicine & Health Sciences Grand Forks, ND 58202

Dr. Basson

Marc D. Basson, MD, PhD, MBA
Professor of Surgery, Pathology, and Biomedical Science
Senior Associate Dean for Medicine and Research
University of North Dakota School of Medicine & Health Sciences
Grand Forks, ND 58202 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: I and other surgeons have previously had the experience of caring for patients with appendicitis who had recently undergone colonoscopy, and wondered if there might be a connection.  However, colonoscopy and appendicitis are both common events, and so it would be difficult to tell whether they are linked or just coincidences from scattered occurrences.

After obtaining appropriate regulatory approvals, we identified almost 400,000 veterans from the US Department of Veterans Affairs database who had undergone screening colonoscopy and compared their rates of appendectomy and acute appendicitis in the week following colonoscopy to rates of appendectomy and appendicitis over each of the following 51 weeks.  We asked the question in several different ways and verified our results by examining surgical and pathology reports.  Depending on how the question was asked and appendicitis or appendectomy defined, rates of appendectomy and appendicitis were clearly 4-9 times higher in the first week after diagnostic colonoscopy.  This wasn’t true when we asked whether appendectomy was more common after several other procedures that also required sedation and contact with the medical system.

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Drinking Coffee Reduced Mortality in Treated HIV-Hepatitis C Co-Infected Patients

MedicalResearch.com Interview with:

Coffee Wikipedia image

Coffee
Wikipedia image

Patrizia Carrieri PhD
INSERM U912 – ORS PACA
IHU – Faculté de Médecine
Marseille, France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study is based on the longitudinal data of the French  ANRS HEPAVIH cohort of patients with HIV and Hepatitis C co-infection. This cohort was set up thanks to a collaboration between INSERM (National Institute of health and medical research) UMR912 in Marseille, the ISPED (public health and epidemiology institute) in Bordeaux and several hospital/university sites. Our INSERM team in Marseille is specialized in the study of the impact of behaviors on HIV and HCV outcomes, including mortality.

We could think that HCV cure was enough to reduce mortality in HIV-HCV patients as the mortality risk was 80% lower in those who were cured of (i.e. who “cleared”) Hepatitis C thanks to treatment.

However, our study showed that, even after HCV cure, sociobehavioral factors still matter: drinking at least 3 cups of coffee a day was associated with a 50% reduction in mortality risk as well as not smoking which was also associated with a reduced mortality risk. This association between elevated coffee intake and reduced mortality risk is probably due to the properties of polyphenols contained in coffee which can protect the liver and also reduce inflammation.

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Liraglutide (SAXENDA) May Lead To Weight Loss By Slowing Stomach Emptying

MedicalResearch.com Interview with:

Prof Michael Camilleri, MD Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Mayo Clinic, Rochester, MN

Prof. Camilleri

Prof Michael Camilleri, MD
Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic
Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER)
Mayo Clinic, Rochester, MN

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Liraglutide is approved for treatment of obesity; the precise mechanisms for the beneficial weight loss are unclear. We are interested to learn whether it is possible to identify people who are more likely to benefit from this treatment.

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H. pylori May Increase Risk of Stomach Cancer By Turning On Subset of Stem Cells

MedicalResearch.com Interview with:
Michael Sigal PhD

Clinical scientist of the Charité — Universitätsmedizin Berlin
Investigator at the Max Planck Institute for Infection Biology 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We have previously found that H. pylori can colonize gastric glands and that in colonized glands the epithelial turnover was increased. We wanted to characterize the mechanisms that control the gland turnover in the stomach.

We found that Axin2, a classic Wnt target gene, marks two different subpopulations of cells with stem cell properties, one of which is Lgr5-positive and the other one Lgr5-negative. Both populations are affected by Rspondin 3, that is produced in myofibroblasts right beneath the stem cell compartment. Rspondin is crucial for stem cell signaling and knockout of Rspondin 3 in myofibroblasts results in loss of Lgr5 and Axin2 expression. Once we increased the bioavailability of Rspondin, that now could also interact with cells outside of the stem cell compartment, we noticed that the number of Axin2 positive stem cells dramatically increased. Of interest, only Lgr5-negative cells expanded in number and proliferate more, while the Lgr5-positive cells remained silenced.

Infection with Helicobacter pylori leads to an expansion of Axin2-positive cells which is driven by increased expression of Rspondin3. Expansion of the long lived stem cell pool could be an explanation for how H. pylori infection increases the risk for gastric cancer.

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Review of Celiac Disease and Nonceliac Gluten Sensitivity

MedicalResearch.com Interview with:

Maureen Leonard, MD MMSc Clinical Director, Center for Celiac Research and Treatment Instructor in Pediatrics, Harvard Medical School Associate Investigator, Nutrition Obesity Research Center, Harvard Medical School MassGeneral Hospital for Children | Pediatric Gastroenterology & Nutrition

Dr. Leonard

Maureen Leonard, MD MMSc
Clinical Director, Center for Celiac Research and Treatment
Instructor in Pediatrics
Associate Investigator, Nutrition Obesity Research Center
Harvard Medical School
Pediatric Gastroenterology & Nutrition
MassGeneral Hospital for Children  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In this systematic review, we discuss the clinical approach to celiac disease and nonceliac gluten sensitivity, highlighting how to distinguish between these two conditions and their management. These disorders cannot be distinguished based on symptoms. A single elevated serology test is not diagnostic for celiac disease, and patients with abnormal serologic testing must be referred to a gastroenterologist for further testing and remain on a gluten-containing diet until their diagnostic evaluation is completed. While the treatment for both conditions is a gluten-free diet, the possibility of long-term complications differs.

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Risk of Inflammatory Bowel Disease Lower In Rural Households

MedicalResearch.com Interview with:

Eric I. Benchimol, MD, PhD, FRCPC Associate Professor of Pediatrics and Epidemiology, University of Ottawa Division of Gastroenterology, Hepatology and Nutrition Children's Hospital of Eastern Ontario Ottawa, ON Canada

Dr. Benchimol

Eric I. Benchimol, MD, PhD, FRCPC
Associate Professor of Pediatrics and Epidemiology, University of Ottawa
Division of Gastroenterology, Hepatology and Nutrition
Children’s Hospital of Eastern Ontario
Ottawa, ON Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We found that living in a rural household (compared to urban households) was protective against developing inflammatory bowel disease (IBD). People living in a rural household were around 10% less likely to get IBD (Crohn’s disease and ulcerative colitis).

While our finding that IBD was more common in people living in urban households was similar to other studies from around the world, there were a number of new, interesting findings:

  1. Living in a rural household was most protective against pediatric-onset IBD. In fact, it was not protective in IBD with onset between ages 18-39, 40-64, or 65 and older at diagnosis.
  2. Living in a rural household in the first 5 years of life was highly protective against IBD later in life.

These findings indicate the importance of early life environmental exposures in the subsequent development of IBD. This effect has been seen in the inflammatory bowel disease literature when examining other environmental risk factors, particularly early-life antibiotic use and air pollution. These risk factors seem to have the strongest effect of increasing the risk of childhood-onset IBD, and not adult-onset disease.

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Study Finds Diet Not Connected to GI Problems in Children With Autism

MedicalResearch.com Interview with:

Bradley James Ferguson, PhD University of Missouri School of Medicine

Dr. Ferguson

Bradley James Ferguson, PhD
University of Missouri School of Medicine 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Many individuals with autism spectrum disorder (ASD) have gastrointestinal problems, such as constipation, irritable bowel syndrome and abdominal pain, but the cause of these GI issues is not currently known. Previous research from our laboratory showed a significant positive relationship between cortisol levels and GI problems, especially for constipation. However, it is possible that other factors such as diet may affect GI functioning, especially since many children have altered diets. This study examined 32 different nutrients in the children’s diets, as assessed by a food frequency questionnaire that assessed the participant’s diet over the past month, and how each nutrient was related to upper and lower GI tract symptom scores over the past month created from the Questionnaire on Pediatric Gastrointestinal Symptoms – Rome III. The results showed no significant relationships between any of the nutrients and GI symptoms, suggesting that diet was not associated with GI symptoms in this sample.

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Proton Pump Inhibitors Linked To Increased Risk of Adverse Effects and and Death

MedicalResearch.com Interview with:

Ziyad Al-Aly MD FASN Assistant Professor of Medicine Co-director for Clinical Epidemiology Center Department of Medicine, Washington University School of Medicine Saint Louis, Missouri

Dr. Ziyad Al-Aly

Ziyad Al-Aly MD FASN
Assistant Professor of Medicine
Co-director for Clinical Epidemiology Center
Department of Medicine, Washington University School of Medicine
Saint Louis, Missouri
Associate Chief of Staff for Research and Education
Veterans Affairs Saint Louis Health Care System

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Proton Pump Inhibitors (PPI) are commonly used, and they are associated with adverse events including kidney disease, dementia, fractures, cardiovascular disease, and pneumonia. We asked the question of whether this translates to increased risk of death.

We conducted this large cohort study to specifically examine the association between PPI use and risk of death. The results consistently showed an association between use of PPI and increased mortality risk. Moreover, there was a graded relationship between duration of PPI use and risk of death in that longer duration of use was associated with incrementally higher risk of death.

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Prebiotics May Help Limit Obesity In Childhood

MedicalResearch.com Interview with:

Raylene Reimer, PhD, RD Professor, Faculty of Kinesiology University of Calgary Department of Biochemistry & Molecular Biology Cumming School of Medicine Full Scientist Alberta Children's Hospital Research Institute

Dr. Reimer

Raylene Reimer, PhD, RD
Professor, Faculty of Kinesiology
University of Calgary Department of Biochemistry & Molecular Biology
Cumming School of Medicine Full Scientist
Alberta Children’s Hospital Research Institute

MedicalResearch.com: What is the background for this study?

Response: The human gut microbiota is a complex and dynamic population of microorganisms that benefit the human host through a variety of microbial activities (e.g. production of vitamins, immune regulation, utilization of dietary fiber). Despite these benefits however, it is now recognized that disruption of the microbiota (dysbiosis) can upset homeostasis and contribute to diseases such as obesity and type 2 diabetes. Manipulation of the gut microbiota to prevent or treat chronic disease is now an area of intense scientific and clinical interest. Dietary prebiotics, such as inulin and oligofructose, are used selectively by host microorganisms to confer a health benefit. Prebiotics have previously been shown to reduce body fat, improve appetite control and reduce blood glucose in adults with overweight or obesity.

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FDgard® Demonstrated Rapid Relief of Symptoms in Functional Dyspepsia

MedicalResearch.com Interview with:

William D. Chey, M.D., F.A.C.G.</strong> Director, Division of Gastroenterology Michigan Medicine Gastroenterology Clinic Ann Arbor, Michigan

Dr. Chey

William D. Chey, M.D., F.A.C.G.
Director, Division of Gastroenterology
Michigan Medicine Gastroenterology Clinic
Ann Arbor, Michigan

MedicalResearch.com: What is the background for this study?

Response: Functional Dyspepsia (FD), which is persistent or recurring upper abdominal pain, burning, or fullness with no known organic cause, is a relatively common and often frustrating condition. The precise causes of this condition are unknown, but problems with mild inflammation, leakiness of the lining of the gut, overactive sensation, and abnormal contractions of the upper digestive tract are thought to play a role in many patients. FD often reoccurs over time and it is an area of high unmet medical need.

Functional Dyspepsia can have a significant impact on quality of life. Currently, off-label medications are used to treat FD, as there is no U.S. Food and Drug Administration (FDA)-approved pharmaceutical product for the condition.

An estimated 62 percent of FD patients suffer from Epigastric Pain Syndrome (EPS, which is epigastric pain or burning), while an estimated 73 percent of FD patients suffer from Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness); 35 percent suffer from both.

In this study, we compared the efficacy of a unique encapsulated formulation of caraway oil and l-Menthol, the primary component in peppermint oil), (COLM-SST) to placebo in patients taking their usual Functional Dyspepsia medications. Caraway oil contains carvone and d-limonene, which have gastroprotective and prokinetic effects; l-Menthol has anti-inflammatory, prokinetic, analgesic and gastroprotective effects.

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First Report Of A Therapeutic Vaccine For Gluten Sensitive Celiac Disease

MedicalResearch.com Interview with:
Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MALeslie Williams, BS, RN, MBA

Director, Founder, President and
Chief Executive Officer and

Dr Robert P Anderson MBChB BMedSc PhD FRACP
Chief Scientific Officer
ImmusanT, Cambridge, MA

MedicalResearch.com: What is the background for this study?

Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period.

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Novel Peppermint Oil Formulation Designed To Control Irritable Bowel Symptoms

MedicalResearch.com Interview with:

Brooks D. Cash, MD</strong> Chief, Gastroenterology Division Professor of Medicine University of South Alabama Mobile, AL 36688

Dr. Cash

Brooks D. Cash, MD
Chief, Gastroenterology Division
Professor of Medicine
University of South Alabama
Mobile, AL 36688

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Irritable bowel syndrome (IBS) is a chronic functional disorder characterized by multiple symptoms including, but not limited to, abdominal pain or discomfort, constipation, diarrhea, urgency of bowel movement (BM), a sensation of incomplete evacuation, pain at evacuation, abdominal bloating, and passage of gas or mucus. IBS can be classified into four primary subtypes: mixed IBS (IBS-M), diarrhea-predominant IBS (IBS-D), constipation-predominant IBS (IBS-C), and unsubtyped IBS (IBS-U). Among adult patients with IBS, a sizeable proportion suffers from IBS-M, with prevalence rates among IBS patients estimated to be between 44% to 66%. Because of the variability in symptoms associated with IBS-M and the lack of effective or approved therapies, clinicians often face challenges in managing this common IBS subtype.

PO and its active ingredient, l-Menthol, are kappa opioid agonists, possess smooth muscle calcium channel antagonist and serotonergic (5HT3) antagonist properties, and exert anti-inflammatory, anti-infective, and carminative effect. A recent meta-analysis of medical therapies for IBS found that PO had the lowest number needed to treat among the various options evaluated. The previously published IBS Reduction Evaluation and Safety Trial (IBSREST) showed that PO-SST, a novel formulation of PO using solid-state microspheres to target delivery to the small intestine, was an effective IBS therapy at 24 hours, with improved efficacy at 4 weeks in a combined group of IBS-M and IBS-D patients. In view of the unmet need in IBS-M, we performed a post hoc analysis of the effects of PO-SST among only the IBS-M patients from the IBSREST trial.

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Genetic Marker Can Determine Cirrhosis Patients Who Do Not Benefit From Hepatitis C Cure

MedicalResearch.com Interview with:

Dr. Winston Dunn, MD Assistant Professor The University of Kansas Medical Center

Dr. Dunn

Dr. Winston Dunn, MD
Assistant Professor
The University of Kansas Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is widely believed that everyone with HCV can be cured with the medications now a day. But sadly, about 5% of the patients already have very bad damage done to the liver. We call this decompensated cirrhosis. Our medication is still very effective in curing the virus, but in decompensated cirrhosis, curing the virus is not always enough.

Only about half to two-thirds of patients with decompensated cirrhosis clinically gets better, but the remaining struggles along or even gets worse after the cure. That is the problem. So, our research was to understand why that was.

We used genetic factor to predict which patient would get better and which patient would not. We found that a gene previous found to be predictive of fatty liver and fibrosis is also predictive of recovery in this setting.

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New Drug May Protect Gut From Antibiotic-Resistance Genes

MedicalResearch.com Interview with:

Synthetic Biologics, Inc.

Synthetic Biologics, Inc.

Sheila Connelly, PhD
Vice President, Research
Synthetic Biologics, Inc.

MedicalResearch.com: What is the background for this study?

Response: Synthetic Biologics, Inc. is focused on the protection and preservation of the gut microbiome which is the diverse collection of microorganisms that live in the intestinal tract. We are learning that the gut microbiome plays a key role in health. Negative changes to the microbiome, called dysbiosis, are linked to disease states including allergies, autism, and obesity, among a rapidly growing list of other conditions. A consequence of using antibiotics is that, in addition to fighting the bacterial infection being treated, they also kill the gut microbiota. The space left in the gut by the dead bacteria allows other surviving bacteria, many times opportunistic pathogens or microbes that are resistant to multiple antibiotics, to overgrow and fill the open niches. Exposure to antibiotics, particularly broad-spectrum antimicrobials, such as penicillins and cephalosporins, is a major risk factor for acquiring a potentially deadly Clostridium difficile infection.

Dr-Sheila-Connelly.jpg

Dr. Sheila Connelly

Another consequence of antibiotic use is the emergence of antibiotic-resistant organisms. Widespread use of antibiotics provides selective pressure for the evolution of lethal, multi-drug resistant pathogens, termed “nightmare bacteria”. The gut microbiome acts as a reservoir of antibiotic resistance that can be triggered, by antibiotic exposure, to acquire and propagate resistance genes.

A way to protect the microbiome and reduce antibiotic resistance is to limit exposure of the gut microbiota to antibiotics. To this end, we developed an antibiotic inactivation strategy using a beta-lactamase enzyme to degrade beta-lactam antibiotics in the GI tract before they can harm the gut microbiome. Beta-lactamases are naturally-occurring bacterial enzymes that confer resistance to beta-lactams, the most widely used broad spectrum antibiotics, and their presence is normally considered an obstacle to efficacious infection control. We took advantage of the highly efficient antibiotic degradation activity of a beta-lactamase and developed SYN-004 (ribaxamase). Ribaxamase is a beta-lactamase engineered to inactivate penicillins and most cephalosporins, formulated for oral delivery, and intended for use with IV beta-lactam antibiotics to degrade the antibiotics in the GI tract to protect the microbiome.

Ribaxamase was demonstrated to significantly reduce the occurrence of C. difficile disease in a recently completed Phase 2b clinical study. The study met its primary endpoint by demonstrating that ribaxamase, when delivered orally with IV ceftriaxone, significantly reduced C. difficile disease in patients treated for a respiratory tract infection. Ribaxamase also resulted in a significant reduction in new colonization by vancomycin-resistant enterococcus (VRE).

For the current study, pig models of antibiotic-mediated gut dysbiosis were established using three classes of beta-lactam antibiotics, a cephalosporin, ceftriaxone, a penicillin, amoxicillin, and a carbapenem, ertapenem. The ceftriaxone model was used to evaluate the protective effect of ribaxamase on the microbiome and the amoxicillin and ertapenem models are intended for evaluation of pipeline products.

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Tofacitinib -XELJANZ: Potential New Treatment Option For Moderate To Severe Ulcerative Colitis

MedicalResearch.com Interview with:

William J. Sandborn, MD Professor of Medicine and Adjunct Professor of Surgery Chief, Division of Gastroenterology Vice Chair for Clinical Operations, Department of Medicine Director, UCSD IBD Center University of California San Diego and UC San Diego Health System

Dr. Sandborn

William J. Sandborn, MD
Professor of Medicine and Adjunct Professor of Surgery
Chief, Division of Gastroenterology
Vice Chair for Clinical Operations, Department of Medicine
Director, UCSD IBD Center
University of California San Diego and
UC San Diego Health System

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is still a substantial unmet need for new treatments for patients with ulcerative colitis.

A previous Phase II study had suggested that tofacitinib might be effective for short term therapy of ulcerative colitis. The patients in that study for the most part had not failed anti-TNF therapy. Now we report the findings from 3 large Phase III trials, two short term trials and one long term trial, demonstrating that tofacitinib 10 mg twice daily is effective for short term therapy, and that both 5 mg and 10 mg twice daily is effective for long term therapy. We also demonstrated that tofacitinib is effective both in patients who have not failed anti-TNF therapy and patients who have failed anti-TNF therapy.

The study demonstrated induction of clinical remission, clinical response and mucosal healing (flexible sigmoidoscopy improvement) over the short term, and maintenance of clinical remission, clinical response, and mucosal healing over the long term.

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Vagotomy May Point To Gut Origin of Parkinson’s Disease

MedicalResearch.com Interview with:

Karin Wirdefeldt, MD, PhD</strong> Associate professor Karolinska Institutet Stockholm, Sweden

Dr. Wirdefeldt

Karin Wirdefeldt, MD, PhD
Associate professor
Karolinska Institutet
Stockholm, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It has been hypothesized that Parkinson’s disease may start in the gut and spread to the brain via the vagal nerve. We found that people who had a truncal vagotomy (ie, the nerve trunk fully resected) at least 5 years earlier were less likely to develop Parkinson’s disease compared to people without vagotomy or people who had a selective vagotomy (ie, only branches of the nerve resected).

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Fecal Transplantation Reduced Hospitalizations and Improved Cognitive Function in Cirrhosis Trial

MedicalResearch.com Interview with:

Jasmohan S. Bajaj, M.D. Virginia Commonwealth University Associate Professor Department of Internal Medicine Division of Gastroenterology

Dr. Bajaj

Jasmohan S. Bajaj, M.D.
Virginia Commonwealth University
Associate Professor
Department of Internal Medicine
Division of Gastroenterology

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hepatic encephalopathy is a devastating complication of cirrhosis, which often recurs despite standard of care therapy with lactulose and rifaximin. This has a basis in an altered gut milieu therefore we need to change that in a more meaningful way to help patients. This was an FDA-monitored Phase I safety study of Fecal microbiome transfer (FMT) using a rationally-derived donor compared to standard of care.

We found that FMT was safe and was associated with lower all-cause and hepatic encephalopathy-related hospitalizations over 5 months compared to standard of care.

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Athletes’ Microbiome May Be Conditioned For Performance

MedicalResearch.com Interview with:
Dr. Orla O’Sullivan

Computational Biologist,
Teagasc Food Research Centre,
Moorepark, Co. Cork,
Ireland 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Previously we had demonstrated that professional rugby players had significantly increased microbial diversity compared to both low and high BMI controls. This microbial diversity correlated with creatine kinase levels in the blood (which we had used as a proxy for exercise) and protein intake. In this present study we went a step further and demonstrated that these same athletes had distinct functional potential in their gut microbes compared to controls and furthermore both the host derived ( urine) and bacterial derived ( faecal water) metabolites were also distinct in the athlete group. In particular we found that the athlete’s microbiome is primed for tissue repair and to harness energy from the diet, reflecting the significant energy demands and high cell-turnover evident in elite sport.

Thus, the state of physical fitness is not limited to the host alone; it appears to also include conditioning of the microbiota.

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Vitamin D Deficiency Highly Prevalent in Pediatric Irritable Bowel Syndrome

MedicalResearch.com Interview with:

Benjamin Udoka Nwosu, MD, FAAP Associate Professor of Pediatrics Division of Endocrinology University of Massachusetts Medical School Worcester, Massachusetts

Dr. Nwosu

Benjamin Udoka Nwosu, MD, FAAP
Associate Professor of Pediatrics
Division of Endocrinology
University of Massachusetts Medical School
Worcester, Massachusetts

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Vitamin D deficiency has been reported in various gastrointestinal disorders but the vitamin D status of children and adolescents with irritable bowel syndrome (IBS) has not been previously characterized.

Secondly, the vitamin D status in IBS has not been compared to those of other malabsorption syndromes such as irritable bowel syndrome, lactose intolerance, and celiac disease.

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Insufficient Evidence To Screen Asymptomatic People For Celiac Disease

MedicalResearch.com Interview with:

Ann Kurth, Ph.D., C.N.M., R.N.

Dr. Ann Kurth

Dr. Ann Kurth, Task Force member
Dean of the Yale School of Nursing
Adjunct professor
New York University College of Nursing and the College of Global Public Health.

MedicalResearch.com: What is the background for this study?

Response: Celiac disease, an immune disorder where people should not eat food with gluten, is fairly prevalent. When people with celiac disease eat foods containing gluten, which is found in wheat, rye and barley, their body responds by inflaming or destroying villi—the tiny, fingerlike projections on the inner lining of the small intestine–which prevents the body from absorbing the necessary nutrients from food.

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Patients With Clostridium difficile Infections Should Have Need For Gastric Acid Suppression Reassessed

MedicalResearch.com Interview with:

Sahil Khanna,

Dr. Sahil Khanna

Sahil Khanna, M.B.B.S. MS
Division of Gastroenterology and Hepatology
Mayo Clinic, Rochester, Minnesota

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Clostridium difficile infection (CDI) is the most common cause of hospital-acquired diarrhea and has recently shown increasing incidence especially in the community. Novel risk factors for CDI development include the use of gastric acid suppression medication, presence of systemic comorbid conditions, C difficile carriage in water and food sources, amongst others.

Gastric acid suppression medications such as proton-pump inhibitors (PPIs) and histamine-2 receptor blockers (H2Bs) are commonly prescribed and consumed over the counter for gastroesophageal reflux disease, peptic ulcer disease, or functional dyspepsia, but they are also sometimes prescribed for unnecessary indications, which leads to overuse of these medications. Recurrent CDI after a primary infection is a major problem, with the risk being as high as 50% to 60% after 3 or more Clostridium difficile infections. Data on the association between acid suppression and recurrent CDI are conflicting and therefore we performed a systematic review and meta-analysis to study the association between the use of gastric acid suppression medications and the risk of recurrent CDI.

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Viral Bacterial Parasites Called Phages Drive Co-Evolution of Gut Microbiome

MedicalResearch.com Interview with:

Dr Pauline Scanlan Royal Society-Science Foundation Ireland University Research Fellow/APC Faculty, APC Microbiome Institute, Biosciences, University College Cork, Éire

Dr. Scanlan

Dr Pauline Scanlan
Royal Society-Science Foundation Ireland University Research Fellow/APC Faculty,
APC Microbiome Institute, Biosciences,
University College Cork, Éire

MedicalResearch.com: What is the background for this study?

Response: The human gut is host to an incredible diversity of microbes collectively known as the gut microbiome. Each of us has a unique collection of bacterial strains that form part of the gut microbiome. This uniqueness is of potentially crucial importance with respect to host health as we know that differences in bacterial strain diversity within species could have a range of positive or negative consequences for the human host. For example, some strains of a given bacteria are harmless whilst another strain of the same bacterial species could kill you. A classic example of such a difference in strain functionality is exemplified by the gut bacterium Escherichia coli – one strain called E. coli Nissle 1917 is used as a probiotic and another, E. coli O157:H7, has been responsible for a number of deadly food-borne pathogen outbreaks. Therefore a better understanding of what drives bacterial strain diversity is not just fundamental to our understanding of the ecology and evolution of microbes but is also highly relevant for improvements in human health and disease prevention.

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Protective Bacteria May Reverse Inflammation In Some Forms of IBD

MedicalResearch.com Interview with:
Justin E. Wilson, Ph.D 
On behalf of the authors
Research Assistant Professor – Laboratory of Jenny Ting
Department of Genetics
Lineberger Comprehensive Cancer Center
The University of North Carolina at Chapel Hill
Chapel Hill, NC 27599

MedicalResearch.com: Could you provide me with some background on this project? Why did you decide to do this research project? What prior work led up to this latest paper?

Response: Previous work from our lab and others discovered two major points about NLRP12:
a) NLRP12 suppresses inflammation in response to bacterial components
b) NLRP12 provides protection against the inflammatory bowel disease colitis and colitis-associated colon cancer (i.e., Nlrp12-defcient mice have greater colon inflammation and inflammation-driven colon cancer).
Therefore, we wanted to know if Nlrp12 was regulating inflammation in the colon by responding to the trillions of intestinal microbes collective referred to as the microbiome. Mounting evidence also indicates that the immune system both responds to and influences the composition of the intestinal microbiome during intestinal health and disease, and we hypothesized that NLRP12 could be one of the important immune components during this process. Moreover, we were also interested in this topic because targeting the microbiome to treat inflammatory disorders and other diseases is an attractive method that has many advantages over immune suppression.

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Frozen Fecal Transplant in Pill Form Found To Reverse C. Diff Infection

MedicalResearch.com Interview with:

Dr. H. L. DuPont MD Director, Center for Infectious Diseases, UTHealth School of Public Health Mary W. Kelsey Chair in the Medical Sciences, McGovern Medical School at UTHealth Professor, Department of Epidemiology, Human Genetics and Environmental Sciences UTHealth School of Public Health Houston, TX 77030

Dr. DuPont

Dr. H. L. DuPont MD
Director, Center for Infectious Diseases, UTHealth School of Public Health
Mary W. Kelsey Chair in the Medical Sciences, McGovern Medical School at UTHealth
Professor, Department of Epidemiology, Human Genetics and Environmental Sciences
UTHealth School of Public Health
Houston, TX 77030

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Many diseases and disorders are associated with “dysbiosis,” where the intestinal microbiota diversity is reduced. This contributes to disease and to the acquisition of antibiotic resistance. Fecal microbiota transplantation (FMT) is successful in conditions with pure dysbiosis (e.g. C diff infection) and a single dose of FMT is curative in most cases.

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Stretta Procedure Improves GERD Symptoms, Reduces Need for PPIs

MedicalResearch.com Interview with:

Dr. Ronnie Fass, MD Professor, School of Medicine Case Western Reserve University

Dr. Ronnie Fass

Dr. Ronnie Fass, MD
Professor, School of Medicine
Case Western Reserve University

MedicalResearch.com: What is the background for this study?

Response: The endoscopic radiofrequency procedure (Stretta) has been used for more than a decade to treat patients with gastroesophageal reflux disease (GERD). Over time, there were several Meta-analyses with variable designs of the Stretta procedure providing conflicting results. Thus, the purpose of the current systematic review and meta-analysis was to determine the efficacy of the Stretta procedure using all currently available controlled and cohort studies.

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Intestinal E. coli Linked to Arthritis in Inflammatory Bowel Disease

MedicalResearch.com Interview with:

Randy Longman, M.D. / Ph.D. Assistant Professor of Medicine Jill Roberts Center and Institute for Research in Inflammatory Bowel Disease Weill Cornell Medicine Division of Gastroenterology and Hepatology Joan and Sanford I. Weill Department of Medicine Department of Microbiology and Immunology New York, NY 10021

Dr. Randy Longman

Randy Longman, M.D. / Ph.D.
Assistant Professor of Medicine
Jill Roberts Center and Institute for Research in Inflammatory Bowel Disease
Weill Cornell Medicine
Division of Gastroenterology and Hepatology
Joan and Sanford I. Weill Department of Medicine
Department of Microbiology and Immunology
New York, NY 10021 

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Inflammatory bowel disease is not limited to intestinal inflammation.  Up to 1/3 of patients with active disease suffer from extra-intestinal manifestations.

The most common extra-intestinal manifestations in IBD is joint inflammation or spondyloarthritis.  Peripheral joint spondyloarthritis  carries a prevalence of 20% in Crohn’s Disease and 10% in Ulcerative Colitis, predominantly affecting joints of the lower limbs.  It has long been suggested that gut bacteria can drive this systemic joint inflammation, but microbial targets have not been characterized.

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Investigational Compound Improves Gut Microbiome Without Long-Term GI Symptoms

MedicalResearch.com Interview with:

Fernando Azpiroz, MD, PhD Chief of the Department of Digestive Diseases University Hospital Vall d’Hebron Autonomous University of Barcelona, Spain

Dr. Fernando Azpiroz

Fernando Azpiroz, MD, PhD
Chief of the Department of Digestive Diseases
University Hospital Vall d’Hebron
Autonomous University of Barcelona, Spain

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This open-label, single-arm study, included 26 healthy volunteers who did not have gastrointestinal (GI) symptoms or a history of GI disorders, and were not required to change their diets during treatment. Twenty participants were included in the main evaluation and six were included as control subjects.

Participants in the main study were given HOST-G904 (2.8 g/day) for three weeks, during which time they followed their usual diet. In the evaluation periods (three-day periods immediately before, at the beginning and at the end of the administration), the participants followed a standardized low-fiber diet with one portion of high-fiber foods, at which time the investigators measured the following:

(1) number of daytime gas evacuations for two days;
(2) volume of gas evacuated; and
(3) microbiome composition (as measured by fecal Illumina MiSeq sequencing).

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Intestinal and Blood-Brain Barrier Alterations Linked to Autism Spectrum Disorders

MedicalResearch.com Interview with:

Maria Rosaria Fiorentino, PhD

Dr. Maria Rosaria Fiorentino

Maria Rosaria Fiorentino, PhD
Assistant Professor at Harvard Medical School
Molecular Biologist at Mucosal Immunology and Biology Research Center
Massachusetts General Hospital East
Charlestown, MA 02129-4404

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Autism Spectrum Disorders (ASD) refers to complex neurodevelopmental disorders arising from the interaction of genes and environmental factors. There are no defined mechanisms explaining how environmental triggers can lead to these conditions. One hypothesis based on the gut-brain axis connection suggests that inappropriate antigens trafficking through an impaired intestinal barrier, followed by passage of these antigens through a permissive blood-brain barrier (BBB), can be part of the chain of events leading to the disease.

Many Autism Spectrum Disorders children experience co-morbid medical conditions, including gastrointestinal (GI) dysfunctions whose underlying nature is poorly understood. Several clinical observations describe increased intestinal permeability in ASD with often conflicting findings. Permeability to neuroactive food antigens derived from the partial digestion of wheat (gliadorphins) and cow’s milk (casomorphins) has been reported in ASD. However, while evidence of a permeable gut barrier in ASD is increasingly reported, no information is available concerning a similar breach for the BBB. The BBB is a critical line of defense in the Central Nervous System, limiting the access of circulating solutes, macromolecules, and cells that could negatively impact neuronal activity. Dysfunctions of the BBB have been associated with numerous inflammatory neurologic disorders, such as stroke, epilepsy, multiple sclerosis, Parkinson’s and Alzheimer’s disease.

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Non-Surgical Stretta Therapy For Recalcitrant GERD

MedicalResearch.com Interview with:

Dr. Mark Noar Director of The Heartburn and Reflux Study Center Towson, MD

Dr. Mark Noar

Dr. Mark Noar
Director of The Heartburn and Reflux Study Center
Towson, MD 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The background for this study was developed out of a need to know whether the Stretta procedure was effective in both the short and long-term in all forms of reflux. This included standard refluxing patients who had never had surgery but also in the subpopulation of patients who had recurring reflux after having had reflux corrective surgery. The question to be answered was whether the Stretta procedure would be less effective, more effective, or just as effective in the patient who had had prior surgery compared to patients who did not have surgery.

The main findings were that independent of whether a patient had had surgery for the correction of reflux or just had standard reflux without prior surgery, the Stretta procedure was equally effective in all patient subgroups both in the short-term and the long-term.

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Minimal Acupuncture Seems To Calm Infant Colic

MedicalResearch.com Interview with:
Acupuncture Wikipedia imageDr Kajsa Landgren

Faculty of Medicine, Department of Health Sciences
Lund University, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Infantile colic is common, affecting 10-20% of newborns. These infants have intense crying and fussing, more than 3 hours/day more than 3 days/week. There is no medical treatment, causing desperate parents to seek complementary medicine. The evidence for acupuncture is sparse.

In this trial including 147 infants with colic, we tested two types of acupuncture. Both types of acupuncture were minimal, i.e needles were inserted for only a few seconds without further stimulation.

Group A received only one single needle for 2-5 seconds. Group B received up to five needle insertions for maximum 30 seconds. A third group, C, received no acupuncture. All families came to four extra visits to their Child Health Center where they met a nurse who gave advice and support. During these visits the infants were separated from their parents for five minutes, being alone with an acupuncturist who gave acupuncture to the infants in group A and B, but not to infants in group C. Parents and the nurse were blinded to which group the infant was randomized to.

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Hidradenitis Suppurativa and Inflammatory Bowel Disease Strongly Linked

MedicalResearch.com Interview with:

Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark

Dr. Alexander Egeberg

Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease. Inflammatory bowel disease (IBD) has been associated with increased prevalence of HS, but data has been limited to small studies and even less is known about the concurrence and risk of new-onset IBD in patients with pre-existing HS.

In our study, we found a higher prevalence of Crohn’s disease and ulcerative colitis in patients with HS. Notably, there was a more than two-fold increased risk of new-onset Crohn’s disease and a 63% increased risk of new-onset ulcerative colitis in patients with Hidradenitis suppurativa compared with the general population.

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Stress May Aggravate GI Symptoms in Autism Spectrum Disorder

MedicalResearch.com Interview with:

David Q. Beversdor MD Center for Translational Neuroscience University Hospital University of Missouri Health System Columbia, MO 65212

Dr. David Beversdor

David Q. Beversdor MD
Center for Translational Neuroscience
University Hospital
University of Missouri Health System
Columbia, MO 65212

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Altered stress reactivity, alterations in cytokines and a high incidence of gastrointestinal disturbances have all been observed in autism spectrum disorder (ASD). We wished to examine the interactions between these factors.

What we found was that patients with greater stress reactivity, as indicated by cortisol response in the testing environment, had greater symptomatology involving the lower gastrointestinal tract, which was predominated by constipation.

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ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries

MedicalResearch.com Interview with:

Paul Y. Kwo, MD, FACG Stanford University School of Medicine

Dr. Paul Y. Kwo

Paul Y. Kwo, MD, FACG
Stanford University School of Medicine

MedicalResearch.com: What is the background for this study?

Response: This guideline, which was jointly authored by Drs. Kwo, Cohen, and Lim provides a framework for physicians to approach the very common problem encountered of a patient whose liver chemistries are abnormal. This is particularly relevant as there remain large pools of individuals who have yet to be diagnosed with chronic hepatitis B and C, non-alcoholic fatty liver disease, advanced liver disease as well as less common conditions, all of whom will require evaluation.

In particular, the rise in the prevalence of non-alcoholic fatty liver disease worldwide will be addressed in part by identifying and evaluating these individuals prior to the development of advanced fibrosis. The guideline takes clinicians through a step-wise approach to the evaluation of elevated aminotransferase (ALT and AST), alkaline phosphatase, and bilirubin levels including appropriate historical questions, important physical examination findings, laboratory , radiological evaluation and finally liver biopsy if required.

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Anti–HIV Drug Candidate Prevents Intestinal Inflammation

MedicalResearch.com Interview with:
Prof. Jamal Tazi

Director, Institute for Molecular Genetics
CNRS and University of Montpellier and Executive Committee Member
ABIVAX

MedicalResearch.com: What is the background for this study?

Response: Its long been established that people with HIV, even those treated successfully with antiretroviral treatment, exhibit significantly higher levels of chronic inflammation than HIV-negative people. The causes of this inflammation are many – ongoing viral replication, often in the so-called viral reservoirs, leaky gut syndrome, concomitant viral infections (eg CMV, hepatitis etc).

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Can Probiotics in Yogurt Protect Against Stress and Anxiety?

MedicalResearch.com Interview with:

Elizabeth Bryda, PhD Professor, Director, Rat Resource and Research Center Veterinary Pathobiology University of Missouri Columbia, Missouri

Dr. Elizabeth Bryda

Elizabeth Bryda, PhD
Professor, Director, Rat Resource and Research Center
Veterinary Pathobiology
University of Missouri
Columbia, Missouri

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A number of groups have demonstrated the ability of probiotics to benefit digestive health and there is a growing body of evidence to suggest an association between mental health and “gut health”. We were interested to see if probiotic bacteria could decrease anxiety- or stress-related behavior in a controlled setting using zebrafish as our model organism of choice for these studies.

We were able to show that Lactobacillus plantarum decreased overall anxiety-related behavior and protected against stress-induced dysbiosis (microbial imbalance). The fact that administration of probiotic bacteria also protected other resident gut bacteria from the dramatic changes seen in “stressed” fish not receiving the probiotic was unexpected and suggested that these bacteria may be working at the level of the GI tract and the central nervous system.

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Genetic Predisposition To Irritable Bowel Syndrome Strengthened

MedicalResearch.com Interview with:
Mauro D’Amato
Ikerbasque Research Professor
Head, Unit of Gastrointestinal Genetics, Department of Gastrointestinal and Liver Diseases
BioDonostia Health Research Institute
San Sebastian, Spain

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Irritable bowel syndrome (IBS) is a very common condition, whose underlying pathophysiology is poorly understood. People with IBS often complain certain foods trigger their symptoms and, at least in some patients, incomplete breakdown of carbohydrates may result in malabsorption with diarrhoea, bloating and abdominal pain. At the extreme of the spectrum of such clinical manifestations, this is what happens in a hereditary form of sucrose intolerance, the congenital sucrase-isomaltase deficiency (CSID) due to mutations in the Si gene that lead to defective enzymatic disaccharidase activity in the gut. Because IBS shows genetic predisposition, we tested the hypothesis that mutations and DNA variants affecting SI enzyme function may confer increased risk of IBS. We studied almost 2000 individuals from several clinics from Europe and USA, and found out that rare SI mutations and other more common defective DNA variants are indeed more frequent in patients than healthy controls.

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Without Fiber, Gut Bacteria Begin To Eat Our Intestinal Lining

MedicalResearch.com Interview with:

Mahesh Desai, PhD Principal Investigator Allergology - Immunology - Inflammation Research Unit Department of Infection and Immunity Luxembourg Institute of Health Luxembourg

Dr. Mahesh Desai

MedicalResearch.com: What is the background for this study?

Response: Over the last few decades, our intake of dietary fiber has fallen drastically mainly due to the consumption of processed food, which has been connected to increased cases of intestinal diseases including colon cancer and inflammatory bowel disease. The gut microbiota is essential for us as it allows our body to digest dietary fiber contained in fruits and vegetables, that could otherwise not be processed. Changed physiologies and abundances of the gut microbiota following a fiber-deprived diet have been commonly linked to several intestinal diseases. However, the mechanisms behind these connections have remained poorly understood.

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New Capsule Can Reside in Stomach and Deliver Drugs for Several Weeks After Single Ingestion

MedicalResearch.com Interview with:

C. Giovanni Traverso, MB, BChir, PhD Gastroenterologist and biomedical engineer Division of Gastroenterology at BWH Instructor of medicine at Harvard Medical School.

Dr. Traverso

C. Giovanni Traverso, MB, BChir, PhD
Gastroenterologist and biomedical engineer
Division of Gastroenterology at BWH
Instructor of medicine at Harvard Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We developed a drug delivery system capable of safely residing in the stomach for 2 weeks. Furthermore we demonstrated the capacity of the novel dosage form, in the shape of a star, to protect the drug from the acidic stomach environment and also slowly release drug over the course of 14 days.

We applied this new technology towards efforts targeting the elimination of malaria. Specifically, we focused on a drug called ivermectin that has been used to treat parasites but also has the benefit of being toxic to malaria-carrying mosquitos when they bite someone who has ivermectin in their system.

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Hypertriglyceridemia Markedly Increases Risk of Acute Pancreatitis

MedicalResearch.com Interview with:
Borge G. Nordestgaard, MD, DMSc

Professor, University of Copenhagen
Chief Physician, Dept. Clinical Biochemistry, Herlev and Gentofte Hospital
Copenhagen University Hospital
Herlev, Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Acute pancreatitis is an inflammatory disorder of the pancreas with gallstones and high-alcohol consumption as leading risk factors, while mild-to-moderately increased plasma triglycerides hitherto has been overlooked. We surprisingly found that the risk of developing acute pancreatitis was increased already from triglycerides of 175 mg/dL (2 mmol/L) and above. When triglycerides were above 443mg/dL (5mmol/L) the risk was increased a massive 9-fold. Interestingly, this risk was higher than the corresponding 3.4-fold higher risk for myocardial infarction.

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Researchers Search for Probiotic Factors To Reduce Risk of Calcium Oxalate Kidney Stones

MedicalResearch.com Interview with:

Dr. Hatim A. Hassan Section of Nephrology, Department of Medicine The University of Chicago Chicago, IL 60637

Dr. Hatim A. Hassan

Dr. Hatim A. Hassan MD PhD
Section of Nephrology, Department of Medicine
The University of Chicago
Chicago, IL 60637

MedicalResearch.com: What is the background for this study?

Response: Nephrolithiasis is the second most prevalent kidney disease in USA after hypertension, with a rising prevalence and complications including advanced chronic kidney disease (CKD) and end stage renal disease (ESRD). It remains a major source of patient discomfort and disability, lost working days, and health-care expenditure, with an annual economic cost approaching $10 billion. Hyperoxaluria is a major risk factor for kidney stones (KS), and 70-80% of KS are composed of calcium oxalate. Urinary oxalate is an important determinant of supersaturation, and the risk for stone formation is affected by small increases in urine oxalate. Oxalate is a metabolic end product that cannot be further metabolized and is highly toxic. The mammalian intestine plays a crucial role in oxalate homeostasis, by regulating the amount of absorbed dietary oxalate and providing an avenue for enteric oxalate excretion. Anion exchanger SLC26A6 (A6)-mediated intestinal oxalate secretion plays a critical role in preventing hyperoxaluria and calcium oxalate kidney stones (COKS). Inflammatory bowel disease patients have a significantly increased risk of kidney stones due to the associated enteric hyperoxaluria. Obesity is a risk factor for KS and obese stone formers often have mild to moderate hyperoxaluria. Hyperoxaluria is also emerging as a major complication (developing in > 50% of patients) of bariatric surgery for obesity. With the rising prevalence of obesity and increased utilization of bariatric surgery, it is expected that the incidence of hyperoxaluria and related COKS (including the associated cost burden) will continue to increase at a significant rate. Primary hyperoxaluria (PH) is an inherited disease in which there is endogenous oxalate overproduction, which leads to recurrent KS and/or progressive nephrocalcinosis, ESRD, as well as significant hyperoxalemia, systemic oxalosis and premature death. Systemic deposition of calcium oxalate (oxalosis) leads to bone disease, cardiac arrhythmias, cardiomyopathy, skin ulcers, erythropoietin refractory anemia, and digital gangrene. The only treatment known to fully correct the underlying metabolic defect is liver transplantation or combined kidney-liver transplantation once ESRD develops. In addition, significant hyperoxalemia is also seen in ESRD. Cardiovascular diseases are the leading cause of morbidity and mortality in ESRD patients, and a recent report raised the possibility that the ESRD-associated hyperoxalemia might contribute to this increased risk. Lowering serum oxalate might improve cardiovascular outcomes in ESRD patients if these findings are confirmed.

Unfortunately, there is currently no specific therapy that effectively lowers urine and/or plasma oxalate level(s), and the risk of recurrent COKS, nephrocalcinosis, oxalate nephropathy, ESRD, & systemic oxalosis remains substantial in the absence of treatment.

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Patient-Centered Medical Home Improved Quality of Life in Inflammatory Bowel Disease

Miguel Regueiro, M.D., AGAF, FACG, FACP Professor of Medicine and Professor, Clinical and Translational Science University of Pittsburgh School of Medicine Senior Medical Lead of Specialty Medical Homes University of Pittsburgh Medical Center IBD Clinical Medical Director Division of Gastroenterology, Hepatology, and Nutrition Mezzanine Level, C Wing, 200 Lothrop Street Pittsburgh PA, 15213

Dr. Miguel Regueiro

MedicalResearch.com Interview with:
Miguel Regueiro, M.D., AGAF, FACG, FACP
Professor of Medicine and Professor, Clinical and Translational Science
University of Pittsburgh School of Medicine
Senior Medical Lead of Specialty Medical Homes
University of Pittsburgh Medical Center
IBD Clinical Medical Director
Division of Gastroenterology, Hepatology, and Nutrition
Pittsburgh PA, 15213

MedicalResearch.com: What is the background for this study?

Response: The background for the study is that we created an Inflammatory Bowel Disease (IBD) patient centered medical home in conjunction with our UPMC Health Plan. The IBD medical home has been designated UPMC IBD Total Care and provides whole person care for patients with ulcerative colitis and Crohn’s disease. Unlike primary care medical homes, the gastroenterologist is the principle care provider in this specialty medical home model. We created this medical home to improve the IBD patient experience, provide high quality care, and decrease utilization and cost.

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pH Sensing Molecules May Play a Role in Initiating Inflammatory Bowel Disorders

MedicalResearch.com Interview with:
Cheryl de Valliere, PhD
University Hospital Zurich
Division of Gastroenterology and Hepatology
Zurich Switzerland
and co-authors
Gerhard Rogler, Jesus Cosin Roger, Pedro A. Ruiz

MedicalResearch.com: What is the background for this study?

Response: Inflammatory Bowel Disease (IBD), including ulcerative colitis and Crohn’s disease, gives rise to chronic relapsing inflammation of the gastrointestinal (GI) tract, resulting in a disruption of the epithelial barrier function and exacerbated innate and adaptive immune responses. One of the most important features under these inflammatory conditions is the presence of hypoxic areas where oxygen levels are lower than in normal tissue. It has been widely reported that the main transcription factor regulating cellular responses to hypoxia, hypoxia inducible factor (HIF)-1, is significantly induced in patients with IBD compared with healthy subjects. Furthermore, hypoxia is not only linked to inflammation, but also influences the local tissue pH, leading to an reduction of the pH in the inflamed mucosa compared with the non-inflamed one.

A family of pH-sensing G-protein coupled receptors (GPCRs), including the receptor T-cell death-associated gene 8 (TDAG8) and the ovarian cancer G-protein coupled receptor 1 (OGR1 or GPR68), play an important role in physiological pH homeostasis. At low extracellular pH, second messenger signaling pathways are activated by protons binding to the histidine residues located on the extracellular region of the receptor. Recent studies have reported a link between IBD and this family of pH-sensing receptors. Indeed, TDAG8 has been identified as an IBD risk gene and we have previously reported an increased expression of OGR1 in patients with IBD compared with healthy subjects.

To better understand the basic mucosal inflammatory mechanisms, and foster the development of new treatment options (e.g. pH receptor blockers and OGR1 antagonists) for chronic mucosal inflammatory diseases, we investigated the effects of hypoxia on pH-sensing OGR1 in the intestinal mucosa and associated cells.

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