Dr. Bullitt[/caption]
Esther Bullitt, Ph.D.
Associate Professor
Dept. of Physiology & Biophysics
Boston University School of Medicine
Boston, MA 02118-2526
MedicalResearch.com: What is the background for this study?
Response: We know that saliva has properties that allow us to swallow easily, and to help prevent gum disease and infections in the mouth. But is that really the only use for the 1-2 liters (1-2 quarts) of saliva we produce every day? We decided to test whether a component of saliva, Histatin-5, can help prevent diarrheal disease (Traveler’s Diarrhea by Enterotoxigenic Escherichia coli (ETEC)) that is caused by bacteria commonly found in contaminated food and water.
ETEC are bacteria that have hundreds of thin hair-like fibers on their surface, called pili. These bacteria bind specifically to the surface of the gut using these pili, and the bacteria need to stay bound long enough to initiate disease. Studies by Mike Levine’s group in the 1970’s showed that pili are necessary for enterotoxigenic Escherichia coli (ETEC) to cause disease. No adhesion, no disease.
One aid to remaining bound is the unwinding and rewinding of the pili. These helical fibers can unwind up to 8 times their original length, acting as shock absorbers during fluid flow.
Dr. Amit Singal[/caption]
Amit Singal MD MS
David Bruton Jr. Professor in Clinical Cancer Research
Associate Professor of Medicine
Medical Director of Liver Tumor Program
Clinical Chief of Hepatology
University of Texas Southwestern
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Hepatocellular carcinoma, the most common form of primary liver cancer, often has a very poor prognosis because most cancers are found at a late stage when curative treatment is not available. However, if the cancer is found early, curative therapies are possible and patients can typically live longer than 5 years.
There is currently debate how at-risk patients with chronic liver disease should be screened - with an abdominal ultrasound alone or using a combination of abdominal ultrasound and a blood test called alpha fetoprotein. Many professional societies have traditionally recommended the former, i.e. ultrasound alone, given few data showing a benefit of adding alpha fetoprotein.
Our study examines all available literature examining this question and found using the two tests in combination significantly increases the likelihood of finding the cancer at an early stage. Whereas abdominal ultrasound misses over half of all cancers, using it in combination with alpha fetoprotein can detect two-thirds of cancers at an early stage.
Dr. Ana Vivancos[/caption]
Dr. Ana Vivancos PhD, Principal Investigator
Cancer Genomics Group
Vall d'Hebron Institute of Oncology (VHIO
Barcelona
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Our study was designed to address a key issue in liquid biopsy testing: analytical sensitivity. We know that mutations in plasma of mCRC patients show a wide range in their allelic frequencies (0.01-90%), the biological basis for which remains unclear. We also know that around 35% of cases show very low mutant allele fractions (MAFs), < 1%, therefore highlighting the need of using high sensitivity techniques in the routine lab in order to properly detect mutations.
We have compared two different testing methods that are being used in liquid biopsy:
Digital PCR (OncoBEAM RAS test, BEAMing) with a limit of detection of 0.02% vs qPCR (Idylla ctKRAS test, Biocartis) with an analytical sensitivity of 1%.
Our findings indicate that detection sensitivity decreases for the qPCR based method in cases with low MAF (<1%) and more so when MAF values are very low (<0.01%).
Dr. Sung[/caption]
Dr Valerie Sung MBBS (Hons) FRACP MPH PhD
Department of Paediatrics
The University of Melbourne
Murdoch Childrens Research Institute
Parkville, Australia
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Infant colic is excessive crying in babies less than 3 months old with no underlying medical cause. It affects 1 in 5 newborns, is very distressing, and is associated with maternal depression, Shaken Baby Syndrome, and early cessation of breastfeeding. Up to now, there has been no single effective treatment for colic. The probiotic Lactobacillus reuteri DSM 17938 has recently shown promise but results from trials have been conflicting. In particular, a previous trial from Australia, the largest in the world so far, did not find the probiotic to be effective in both breastfed and formula-fed infants with colic.
This international collaborative study, which collected raw data from 345 infants from existing trials from Italy, Poland, Canada and Australia, confirms Lactobacillus reuteri to be effective in breastfed infants with colic. However, it cannot be recommended for formula-fed infants with colic.
Compared to a placebo, the probiotic group was two times more likely to reduce crying by 50 per cent, by the 21st day of treatment, for the babies who were exclusively breastfed. The number needed to treat for day 21 success in breastfed infants was 2.6.
In contrast, the formula fed infants in the probiotic group seemed to do worse than the placebo group, but the numbers for this group were limited.
Dr. McCoul[/caption]
Dr. Edward D. McCoul, MD, MPH
Ochsner Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Population-level data suggests a link between gastroesophageal reflux disease and cancer of the throat and sinuses in adults over 65 years of age. T
he strength of association between reflux and cancer is strongest for anatomic sites closest to the esophagus, where acid and other stomach contents may have the greatest exposure.
Clostridium difficile
Dr. Wilcox[/caption]
Charles Melbern (Mel) Wilcox, MD, MSPH
Director of the division of Gastroenterology and Hepatology
University of Alabama-Birmingham
MedicalResearch.com: What is the background for this survey? What are the main findings?
Response: Nearly every person experiences pain at some point in their life – for many, the pain is acute and occasional, but for others, the pain is chronic and can be debilitating. Research shows that more than 25.3 million Americans suffer from daily pain and, every year, consumers purchase more than $20 billion per year on over-the-counter (OTC) pain medicines. In my work with the American Gastroenterological Association, we set out to explore the behaviors, beliefs, and misunderstandings that Americans have when it comes to OTC pain medicines. We surveyed 1,015 U.S. adults and 251 gastroenterologists to gain insight on how they were approaching pain management and OTC pain medicine use.
The survey found that Americans are routinely ignoring OTC pain medicine labels and are not consulting their health-care professionals about their pain before taking OTC pain medicines. As a direct result, gastroenterologists are noticing their patients experiencing complications and unintentional overdose symptoms. They see an average of 90 overdose cases each year, about two a week, due to OTC pain medicine overdose.
Ninety percent of gastroenterologists believe their patients require more and better education on how to use OTC pain medicine safely. They find that patients are not fully understanding the harms associated with taking too much. When asked why patients take more than the recommended dose, Americans say that they are confident in their ability to manage their medication (32 percent) or they wanted to feel better faster, mistakenly thinking more medicine would be the solution (73 percent).
Chase Spurlock, PhD, CEO of IQuity Inc. and
Thomas M. Aune, PhD,
Co-Founder of IQuity Inc.
MedicalResearch.com: Why did you develop IsolateIBS-IBD?
Response: Isolate IBS-IBD arose from work started at Vanderbilt University, which found that autoimmune diseases exhibit distinct RNA patterns in blood and that these patterns often are specific for a particular disease. In our longitudinal and cross-sectional studies of many human conditions that span both autoimmune and non-autoimmune disease categories, we found that differences detected at the level of RNA can provide an accurate snapshot of a person’s disease. Using RNA, we can tell at a very early stage if a pattern exists that indicates a specific disease. With this information, providers can initiate treatment plans sooner and have an additional tool in their toolbox when making diagnostic determinations.
We developed this test because the symptoms of IBS and IBD are very similar, which can make it difficult and time-consuming for doctors to achieve an accurate diagnosis. IsolateIBS-IBD helps providers distinguish between the two conditions. It shouldn’t be viewed as a replacement or stand-alone test — doctors still need to use it in conjunction with clinical observation combined with traditional tests and procedures like a CT scan or endoscopic examination of the colon — but it can dramatically speed the diagnostic process. IQuity delivers results to providers within seven days of receiving the patient’s sample in the laboratory, allowing doctors to begin discussing a course of treatment as soon as possible.
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.
Dr. Quigley[/caption]
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.
Dr. Chey[/caption]
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.
Ron Walborn Jr.[/caption]
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.
Dr. Kaplan[/caption]
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.
Dr. Cash[/caption]
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]
Dr. Basson[/caption]
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.
Coffee
Prof. Camilleri[/caption]
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.
Dr. Leonard[/caption]
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.
Dr. Benchimol[/caption]
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:
Dr. Ferguson[/caption]
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.
Dr. Ziyad Al-Aly[/caption]
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.
Dr. Reimer[/caption]
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.
Dr. Cash[/caption]
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.
Dr. Dunn[/caption]
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.
Dr. Sandborn[/caption]
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.