Author Interviews, Gastrointestinal Disease / 24.05.2021

MedicalResearch.com Interview with: Nicholas J. Talley, MD, PhD Pro Vice-Chancellor, Global ResearchUniversity of Newcastle, Australia Adjunct Professor of Medicine Division of Gastroenterology and Hepatology; Department of Medicine University of North Carolina at Chapel Hill    MedicalResearch.com: What is the background for this study? What is meant by Eosinophilic Gastritis and/or Duodenitis?  Response: Eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) is an eosinophilic gastrointestinal disease (EGID) characterized by chronic gastrointestinal (GI) symptoms and elevated eosinophils in the stomach and/or the duodenum (the first part of the small intestine). When patients have both EG and EoD, it is sometimes referred to as eosinophilic gastroenteritis (EGE). You may have heard of eosinophilic esophagitis (EoE), which is the more well understood EGID characterized by elevated eosinophils in the esophagus. Until recently, EG/EoD was thought to be very rare, but prevalence had never been assessed in a prospective, systematic manner. New research indicates that EG/EoD may be a common cause of chronic, moderate-to-severe GI symptoms. Related, millions of patients in the United States suffer with chronic GI symptoms or are diagnosed with a functional GI disorder (FGID). FGIDs are diagnoses of exclusion, and excitingly the study results we present at DDW 2021 suggest that EG/EoD may be the underlying cause of many of these patients’ chronic, moderate-to-severe GI symptoms. (more…)
Author Interviews, Gastrointestinal Disease, Race/Ethnic Diversity / 23.05.2021

MedicalResearch.com Interview with: Edward L. Barnes, MD, MPH Assistant Professor of Medicine Division of Gastroenterology and Hepatology UNCHealth Care and a medical advisor to the Global Healthy Living Foundation MedicalResearch.com: What is the background for this study? Response: Although historically inflammatory bowel diseases (IBDs) have been considered diseases of non-Hispanic whites, the current burden of Crohn’s disease (CD) and ulcerative colitis (UC) in minority populations is largely unknown. I n our study, we evaluated the relative prevalence of CD and UC across racial and ethnic groups within the National Patient-Centered Clinical Research Network (PCORnet) and compared the racial/ethnic distribution of IBD in PCORnet to that of the United States (US) census data, the overall PCORnet population, and PCORnet patients with selected immune-mediated conditions. (more…)
Author Interviews, COVID -19 Coronavirus, Gastrointestinal Disease / 27.08.2020

MedicalResearch.com Interview with: Dr. Arvind J. Trindade, MD Director of Endoscopy Long Island Jewish Medical Center Associate professor at Feinstein Institutes for Medical Research Division of Gastroenterology, Zucker School of Medicine Hofstra/Northwell, Northwell Health System New Hyde Park, NY MedicalResearch.com: What is the background for this study? Response: Although most patients with COVID-19 present with respiratory symptoms, gastrointestinal (GI) symptoms have also been reported in up to 25% of patients. Some case reports have shown acute pancreatitis as the initial presentation in patients with COVID-19, however the literature supporting this is limited. Our study aimed to report the point prevalence, risk factors, and outcomes of hospitalized patients with COVID-19 presenting with acute pancreatitis in a large health system and to compare outcomes of pancreatitis in patients without COVID-19. (more…)
Author Interviews, Gastrointestinal Disease / 06.05.2020

MedicalResearch.com Interview with: Gregory S. Sayuk, MD, MPH John T. Milliken Department of Medicine Division of Gastroenterology Associate Professor of Medicine and Psychiatry Associate Director, Fellowship Training Program Washington University School of Medicine MedicalResearch.com: What is the background for this study? Response: The primary objective of this analysis, “Plecanatide for Patients with Chronic Idiopathic Constipation and Irritable Bowel Syndrome‒Constipation: Analysis of Abdominal Pain from Four Randomized Phase 3 Clinical Trials,” was to determine the impact of plecanatide on abdominal pain in patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), in addition to comparing efficacy results in patient populations with minimal to mild pain versus moderate to severe pain at baseline. This was a post hoc analysis of data from the four large, phase 3 plecanatide pivotal trials in CIC and IBS-C. (more…)
Author Interviews, Circadian Rhythm, Gastrointestinal Disease, Genetic Research, Weight Research / 13.10.2019

MedicalResearch.com Interview with: Marco Colonna, MD Robert Rock Belliveau MD Professor Pathology & Immunology Washington University School of Medicine Qianli Wang MD-PhD Student MSTP student Washington University School of Medicine MedicalResearch.com: What is the background for this study? Response: Many aspects of the mammalian digestive system including gut motility, nutrient absorption, and microbiota follow a daily rhythm. This circadian rhythm is generated by the cyclic expressions of molecular clock genes thought to be present in most cells. Group 3 innate lymphoid cells (ILC3) are lymphocytes residing in the intestinal mucosa that respond rapidly to activation in both homeostatic and inflammatory settings. Namely, ILC3s help maintain the mucosal barrier, regulate epithelial lipid transport, and protect against bacterial enteric infections. As tissue resident cells within the highly dynamic and rhythmic environment of the intestine, it may be advantageous for ILC3s to also be synchronized with the circadian rhythm.  (more…)
Author Interviews, Gastrointestinal Disease, Pediatrics, Personalized Medicine / 26.09.2019

MedicalResearch.com Interview with: James P. Franciosi, MD Chief of Gastroenterology, Hepatology and Nutrition Nemours Children's Hospital MedicalResearch.com: What is the background for this study? Response: Eosinophilic Esophagitis (EoE) is a chronic inflammation of the esophagus that is driven by eosinophils. A common class of medications used for this condition are called Proton Pump Inhibitors, or PPIs, which block the production of gastric acid in the stomach. Currently only 30 to 60 percent of children with EoE respond well when treated with PPIs. We hypothesized that genetic variants in the genes for CYP2C19 and STAT6 could plausibly be associated with response to PPI therapy for EoE. (more…)
Annals Internal Medicine, Author Interviews, Environmental Risks, Gastrointestinal Disease / 14.09.2019

MedicalResearch.com Interview with: Philipp Schwabl, MD Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna Vienna, Austria MedicalResearch.com: What is the background for this study? Response: There is a lot of research published about microplastics being present in the ocean and subsequently also being found in the gut of sea animals, however there were no investigations if also humans involunterily ingest microplastics. This gave us rationale to perform a pilot study. (more…)
Author Interviews, Dermatology, Gastrointestinal Disease, JAMA / 11.07.2019

MedicalResearch.com Interview with: Prof Ching-Chi Chi, MD, MMS, DPhil (Oxford) Department of Dermatology Chang Gung Memorial Hospital, Linkou Guishan Dist, Taoyuan 33305 Taiwan MedicalResearch.com: What is the background for this study? Response: Hidradenitis suppurativa (HS) and inflammatory bowel disease (IBD) are inflammatory diseases that share common clinical manifestations, genetic susceptibility, and immunologic features. For example, both diseases have similar clinical manifestations in the skin and gut, characterized by sterile abscesses in perineal and inguinal areas, scarring, and sinus tract formation. Both diseases have been associated with an increased prevalence of spondyloarthropathy, have common risk factors (smoking and obesity), and respond well to tumor necrosis factor-inhibitors. Some studies have suggested a link between HS and IBD, but data on the association of HS and IBD remain inconsistent and unclear. Therefore, we conducted a meta-analysis to investigate the association of hidradenitis suppurativ with IBD. (more…)
Author Interviews, Baylor University Medical Center Dallas, Gastrointestinal Disease / 28.05.2019

MedicalResearch.com Interview with: Dr. Rhonda Souza, MD Baylor University Medical Center Center for Esophageal Research Dallas, TX 75246  MedicalResearch.com: What is the background for this study?   Response: Eosinophilic esophagitis (EoE) is a modern disorder of the esophagus caused by an allergy to certain foods. EoE causes esophageal symptoms like difficulty swallowing and heartburn and is diagnosed when biopsies of the esophagus taken during endoscopy show numerous eosinophils, which are a type of inflammatory blood cell.  There are few established treatments for EoE. One such treatment is a diet that eliminates the offending food allergens, and another is to use steroids to reduce the number of eosinophils in the esophagus. However, the most common treatment for adults with eosinophilic esophagitis is to use proton pump inhibitors (PPIs), which block the proton pumps in stomach cells that make acid.  In earlier studies, we found that PPIs also can block proton pumps in esophageal cells.  Those proton pumps are activated by chemicals that the body produces in response to allergens including interleukin (IL)-13 or IL-4.  Il-13 and IL-4, which cause the esophagus to produce eotaxin-3, a molecule that attracts eosinophils. What remained unknown, however, was the mechanism whereby these interleukins activate proton pumps in the EoE esophagus. In our present study, we explored whether IL-4 works by increasing calcium levels in esophageal cells from EoE patients. (more…)
Author Interviews, Gastrointestinal Disease, JAMA, Microbiome / 16.01.2019

MedicalResearch.com Interview with: Samuel P. Costello MBBS Inflammatory Bowel Disease Service, Department of Gastroenterology The Queen Elizabeth Hospital Australia MedicalResearch.com: What is the background for this study? Response: Ulcerative colitis (UC) is an inflammatory bowel disease that has high rates of persistent or relapsing symptoms despite available therapies. Many of these therapies also have the potential for unacceptable side effects including allergy, intolerance, serious infection and malignancy due to long-term immunosuppression. It is for these reasons that new therapies for Ulcerative colitis are required; particularly therapies that target novel pathways and are not immune suppressing. (more…)
Author Interviews, Gastrointestinal Disease / 16.01.2019

MedicalResearch.com Interview with: Dr. Peter Stanich MD Assistant Professor of Gastroenterology, Hepatology and Nutrition The Ohio State University Wexner Medical Center and College of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We knew of toilet stools from popular culture and wanted to study this in a scientific way. This is something that patients, family and friends always ask about and we wanted to start the process of assessing it more rigorously to see if they are beneficial.  (more…)
Author Interviews, Gastrointestinal Disease, Pharmaceutical Companies / 15.08.2018

MedicalResearch.com Interview with: RedHill Biopharma LtdMr. Gilead Raday, MPhil, MSc Chief Operating Officer RedHill Biopharma Ltd MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Crohn's disease?  How common is it and whom does it affect?  Response: Crohn's disease (CD) is a chronic, relapsing inflammatory gastrointestinal disorder characterized by a variety of symptoms, including severe abdominal pain, diarrhea, bleeding, bowel obstruction, fever and weight loss. The underlying cause of Crohn's is unknown; however, CD is believed to arise secondary to genetic and environmental stimuli. More than 1.5 million people suffer from CD globally and it is prevalent in the U.S., affecting more than 200 people per 100,000. The current standard of care for Crohn's disease is limited to anti-inflammatories, immuno-suppressants and biologics that treat auto-immune disorders. These therapies target symptomatic improvement in the inflammation associated with CD, are widely considered to be of limited efficacy in the long term, and are associated with numerous side effects. This speaks to the great unmet need for an effective therapy for this debilitating disease. Additionally, there is no current therapy that treats the suspected underlying cause of Crohn’s disease. We have developed RHB-104 with the MAP hypothesis in mind, which posits that Crohn's disease is caused by infection by a bacteria, Mycobacterium avium subspecies paratuberculosis (MAP). This is similar to peptic ulcer disease, a condition that was initially associated with stress, smoking, NSAIDs and other behavioral factors, yet was found to be caused by H. pylori bacterial infection in the 1980s, revolutionizing the field of ulcer treatment. Validation of this theory would revolutionize how Crohn's disease is viewed and treated by the medical community and RHB-104 is the only therapy in development targeting MAP infection.  (more…)
Author Interviews, Colon Cancer, Gastrointestinal Disease / 06.06.2018

MedicalResearch.com Interview with: Anas Raed, MD Section of General Internal Medicine Augusta University MedicalResearch.com: What is the background for this study? Response: Colorectal cancer (CRC) incidence and mortality rates have been decreasing in the US since mid 1980s, however, recent evidence shows that incidence and mortality rates of CRC in patients younger than 50 years have been increasing significantly. In spite of the increasing trend of colorectal cancer, routine screening of this population has not been addressed due to lack of evidence and cost-effectiveness. Administering screening colonoscopy for all individuals younger than 50 years might not be feasible and, therefore routine screening colonoscopy for specific age groups might reduce the disparity of the incidence in this disease. (more…)
Author Interviews, Cancer Research, Esophageal, Gastrointestinal Disease, JAMA / 21.12.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Gastrointestinal Disease / 06.11.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Gastrointestinal Disease, Pharmacology / 15.10.2017

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  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]  (more…)
Author Interviews, Diabetes, Gastrointestinal Disease, Lancet, Mayo Clinic, Weight Research / 29.09.2017

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 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. (more…)
Author Interviews, Autism, Gastrointestinal Disease, Nutrition / 14.07.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, JAMA, Mayo Clinic / 29.03.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Gastrointestinal Disease, Microbiome / 01.02.2017

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 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). (more…)
Author Interviews, Gastrointestinal Disease, Hepatitis - Liver Disease / 05.01.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Gastrointestinal Disease / 22.10.2016

MedicalResearch.com Interview with: Christopher V. Almario, MD, MSHPM Assistant Professor of Medicine Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center Cedars-Sinai Center for Outcomes Research and Education Los Angeles, CA MedicalResearch.com: What is the background for this study? Response: Recent drug approvals have increased the availability of biologic therapies for inflammatory bowel disease (IBD). However, the growing number of biologics has also made it more difficult for both patients and healthcare providers to navigate treatment options and to ultimately choose the most appropriate therapy. In this study, we wanted to examine patient decision-making surrounding IBD biologic therapies using conjoint analysis, which is a form of tradeoff analysis that determines how respondents make complex decisions by presenting them with competing product profiles. Here, we quantified the relative importance of 9 biologic therapy attributes (e.g., how the medicine works, how the medicine is received, long-term effectiveness, side-effect profile, etc.) in the decision-making process. (more…)
Author Interviews, Gastrointestinal Disease, Pancreatic / 06.10.2016

MedicalResearch.com Interview with: Dr. Pouria Jandaghi Functional Genome Analysis, Deutsches Krebsforschungszentrum Heidelberg, Germany Department of Human Genetics, McGill University University and Genome Quebec Innovation Centre Montreal, Canada MedicalResearch.com: What is the background for this study? Response: Although the overall five-year survival of all patients with cancer stands at 63%, for pancreatic cancer patients, it is a disheartening 8% - a number that remains largely unchanged for three decades. Of the patients diagnosed with pancreatic cancer, about 85% exhibit pancreatic ductal adenocarcinoma (PDAC). Most of these patients die within 4 to 6 months after diagnosis. The poor prognosis is caused by the its detection at only late stages, and lack of effective options for chemotherapy. The widely used chemotherapeutic agent gemcitabine, confers a median survival advantage of only 6 months, and resistance to therapy develops in the vast majority of patients. Given this poor prognosis of patients with PDAC, there is an urgent need to find more effective therapies. In this study, we set out to investigate potential therapeutic targets by dissecting gene expression profiles of tumors and control samples. Candidate targets were validated with respect to their suitability and analyzed functionally. (more…)
Author Interviews, Gastrointestinal Disease, Nutrition, Science / 29.09.2016

MedicalResearch.com Interview with: Distinguished Professor Kourosh Kalantar-Zadeh RMIT's School of Engineering Australia MedicalResearch.com: What is the background for this study? What are the main findings? 1- The development of "swallow-able gas sensor capsules". This was the final test on animals and focused on the measurement of a food supplement (cinnamon) to show the extraordinary capability of this noninvasive tool that will revolutionise the future of Gastroenterology and Food Sciences 2- That cinnamon can improve the health of the stomach, and hence our overall health, by adjusting the acidity and enzymatic secretion in the stomach. So the good effect of cinnamon is not just a grandparent old advice - It is real. (more…)
Author Interviews, Gastrointestinal Disease, Lancet, Surgical Research / 27.07.2016

MedicalResearch.com Interview with: Mr Steven Brown MBChB, BMedSci, FRCS, MD Reader in Surgery Honorary Secretary to the ACPGBI Consultant colorectal surgeon University of Sheffield, UK MedicalResearch.com: What is the background for this study? Response: Haemorrhoids are common. One in 4 of us will at some time have symptoms that can be directly attributed to piles. Whilst most symptoms will settle spontaneously or with improvement to our lifestyle, there remains a large group of patients who require intervention to reduce symptomatology. Numerous interventions exist ranging from relatively minor office therapy to procedures that may take several weeks to recover from. Haemorrhoidal artery ligation (HAL) is one of the more recent surgical operations for haemorrhoidal therapy. It has been introduced certainly into the UK associated with a significant element of media hype purporting ‘painless surgery for piles’. Substantial subsequent medical literature has also suggested an efficacy rivaling other more invasive procedures. Too good to be true? Perhaps. Several systematic reviews have highlighted the lack of good quality data as evidence for the advantages of the technique. A well designed randomized controlled trial was required. The existing literature on  haemorrhoidal artery ligation at the time of the trial suggested the procedure was most effective for less symptomatic haemorrhoids (those that are associated with bleeding and/or minor prolapse; grade II or mild III piles). These type of haemorrhoids also tend to be the most common requiring intervention. The most frequently used alternative procedure for these grade of haemorrhoids in the UK is rubber band ligation (RBL), a simple office therapy not requiring anaesthetic. Hence participants with this grade of haemorrhoids were chosen as the participants with RBL as the comparator. Multiple outcomes were investigated but a patient reported outcome measure of recurrence was chosen as the primary outcome. (more…)
Author Interviews, Microbiome, Pharmacology / 19.07.2016

MedicalResearch.com Interview with: Mark Pimentel, MD Associate Professor, Medicine Director, GI Motility Program Director, GI Motility Laboratory Cedars-Sinai IBS-C Clinical Advisory Board (Chair) at Synthetic Biologics Los Angeles, CA MedicalResearch.com: What is the background for this study? Dr. Pimentel: The SYN-010 program is based on research from my group at Cedars-Sinai Medical Center, and other researchers and collaborators worldwide, investigating the role of intestinal methane production in functional gastrointestinal disorders. Low levels of intestinal methane are a ubiquitous by-product of normal intestinal microbial digestion; however, elevated intestinal methane levels are correlated with decreased intestinal motility and increased symptom severity in patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Methane in humans is produced almost exclusively by the intestinal microorganism Methanobrevibacter smithii (M. smithii). Highest levels of M. smithii are found in the colon; however, overgrowth of M. smithii into the small intestine has also been observed. Previous work from my laboratory demonstrated that methane production by M. smithii in stool samples from IBS-C patients is inhibited by the lactone form of lovastatin. Lovastatin lactone does not appear to eradicate microbial species in the intestine, which should reduce the risk of intestinal dysbiosis and/or the development of microbial resistance. SYN-010 is a proprietary, modified-release, oral formulation of lovastatin lactone, designed to protect lovastatin lactone from the stomach and release the active ingredient in two different locations of the intestinal tract where the M. smithii reside. SYN-010 exerts its therapeutic effect at the level of the intestinal microbiome and does not require absorption into the systemic circulation or conversion of the active ingredient (lovastatin lactone) to the cholesterol lowering β-hydroxyacid form. (more…)
Author Interviews, Colon Cancer, Cost of Health Care, Gastrointestinal Disease, Vanderbilt / 06.07.2016

MedicalResearch.com Interview with: Erica R. H. Sutton, MD Assistant Professor Department of Surgery, General Vanderbilt MedicalResearch.com: What is the background for this study? What are the main findings? Response: Colorectal cancer is one of the most preventable diseases that we face; however, despite the great strides that we have made in the realm of early detection, many people still do not undergo screenings. We sought to increase the availability of screenings to those in our community who are at high risk for colorectal cancer and uninsured by providing free colonoscopies to them and to examine the cost-effectiveness of this intervention. Over a 12-month period, 682 uninsured people underwent screening colonoscopies, and 9 cancers were detected. Compared to the Surveillance, Epidemiology, and End Results (SEER) registry, our patient population included more early-stage cancers, and our program was found to be cost-neutral. (more…)
Author Interviews, Gastrointestinal Disease, Lancet, Microbiome, Pediatrics / 09.03.2016

MedicalResearch.com Interview with: Phillip I. Tarr, MD Melvin E. Carnahan MD Professor of Pediatrics Director, Pediatric Division of Gastroenterolgy and Nutrition Washington University in St Louis School of Medicine St Louis, MO 63110, USA MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Tarr: There is a longstanding belief that gut bacteria are relevant to the developing necrotising enterocolitis (NEC). We have established dysbiosis in the gut before NEC occurs, suggesting this ecological perturbation might be causal.

(more…)
Author Interviews, Gastrointestinal Disease, Pain Research / 15.01.2016

More on Gastroenterology on MedicalResearch.com MedicalResearch.com Interview with: Prof. Guy Boeckxstaens Translational Research in GastroIntestinal Disorders KU Leuven, Belgium Medical Research: What is the background for this study? What are the main findings? Prof. Boeckxstaens: Patients with IBS have increased abdominal pain for which no efficient therapy is available, mainly as the underlying cause is unclear. In our study, we checked the hypothesis that pain receptors (in particular TRPV1) in the gut wall of IBS patients are more sensitive (sensitized) than those of control subjects. Based on previous work, we focused on histamine, mainly as we had indications that mast cells releasing histamine may be involved in IBS. Interestingly, we noticed that neurons in rectal biopsies were indeed more sensitive to capsaicin, a substance of which we know it selectively acts on the pain receptors of interest. We could demonstrate that histamine sensitizes TRPV1 via interaction with its histamine 1 receptor (H1R). We next showed that treatment with a H1R blocker was able to prevent TRPV1 sensitization. Based on this observation, we decided to start a pilot study evaluating the effect of a H1R blocker, ebastine, in patients suffering from IBS. This study showed that 12 weeks treatment with ebastine indeed improved abdominal symptoms, in particular pain. (more…)
Author Interviews, BMJ, Colon Cancer, Gastrointestinal Disease / 13.12.2015

MedicalResearch.com Interview with: Dr Franco Radaelli Division of Digestive Endoscopy and Gastroenterology Valduce Hospital Como, Italy  Medical Research: What is the background for this study? Dr. Radaelli: Split regimens of bowel preparation are strongly recommended by European and American Guidelines as they have been associated with a higher level of colon cleansing. However, there is still uncertainty on whether the higher level of cleansing associated with a split regimen also results in a higher proportion of subjects with at least one adenoma (adenoma detection rate, ADR), that represents by far a more relevant quality indicator than the level of cleansing itself. On this background, we designed a randomized investigator-blinded controlled trial to evaluate whether a “split regimen” of low-volume 2-L PEG-ascorbate solution was superior to the traditional “full dose, the day before regimen” in terms of ADR. Differently from other studies on bowel preparation, we considered adenoma detection rate  instead of the level of colon cleansing, the primary study end-point, and we designed the sample size accordingly. A precise estimation of the sample size was facilitated by including an homogeneous population of asymptomatic subjects undergoing first colonoscopy after positive-FIT within CRC organized screening program. Besides, ADR represents a very solid end-point due to the very low inter-pathology variability in the differential diagnosis between neoplastic and non-neoplastic lesions, while the assessment of the level of cleansing is hampered by unavoidable degree of subjectivity and higher degree of inter-operator variability. (more…)