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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