Crohn’s Disease: Positive Findings from Phase III Study of Antibiotic Combination

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.  Continue reading

Study Identifies How Medical Marijuana May Ease IBD Symptoms

MedicalResearch.com Interview with:

Beth A. McCormick, Ph.D. Professor and Vice Chair | Department of Microbiology & Physiological Systems Founding Executive Director | University of Massachusetts Center for Microbiome Research Board of Editors | Gastroenterology University of Massachusetts Medical School Worcester, MA 01655

Dr. McCormick

Beth A. McCormick, Ph.D.
Professor and Vice Chair | Department of Microbiology & Physiological Systems
Founding Executive Director | University of Massachusetts Center for Microbiome Research
Board of Editors | Gastroenterology
University of Massachusetts Medical School
Worcester, MA 01655

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

Response: There has been extensive, but to date mostly anecdotal, support for a beneficial role for cannabinoids and cannabis-derived agents to provide benefit for symptoms in individuals suffering from intestinal inflammatory disease (IBD).

Our studies have provided one possible rationale for these previous findings: that there is a constitutively active efflux system at the luminal surface of cells that line the intestine that pumps out one class of lipids of the family known as endocannabinoids. In doing so, the intestine floods this surface with these endocannabinoids in a manner that counteracts the actions of a particular potent stimulators of intestinal inflammation that appears to be over-active in certain forms of IBD. This is most significant because a number of cannabinoids and cannabis-derived agents can mimic the actions of this class of endocannabinoids. Moreover, while cannabinoids and endocannabinoids have been shown to provide anti-inflammatory actions, these studies have identified one mechanism used by the body to localize and focus this protective function at a critical site where pro-inflammatory and anti-inflammatory events intersect, providing new insights into how to treat that imbalance in these process that occurs in certain forms of IBD.

Therefore, there is the immediate opportunity to use this research to identify new therapeutic strategies to treat individuals suffering from IBD that could include either agents extracted from marijuana plants or novel molecules selected based upon superior properties made obvious by this newly defined mechanism.

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Gastric Cancer: Gene Mutation Predictive of Response to Immunotherapy

MedicalResearch.com Interview with:

Wei Zhang, Ph.D. Hanes and Willis Family Professor in Cancer Director Cancer Genomics and Precision Oncology Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, NC  27157-1082

Prof. Zhang

Wei Zhang, Ph.D.
Hanes and Willis Family Professor in Cancer
Director
Cancer Genomics and Precision Oncology
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, NC  27157-1082

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

Response: Gastric cancer is a leading cause of cancer-related death worldwide. Infection by the Helicobacter pylori is the major cause of gastric cancer, which accounts for more than 60% of cases. Despite progress in helicobacter pylori eradication and early cancer diagnosis, the five-year survival rate of gastric cancer remains less than 30%. Gastric cancer is one of the most common cancer types in Asia but the incidence for gastric cancer has seen a steadily increase in the United States in recent years.

Immunotherapy treatment has shown remarkable benefit for some cancer patients whereas others experience toxicities. It is important to identify markers that help oncologists decide which patient would benefit from this promising new treatment strategy. It has been suggested that gastric cancer that is positive for Epstein-Barr Virus is likely more responsive to immunotherapy but only about 10% of gastric cancer patients belong to this category. More potential markers are urgently needed for clinical practice.

There is accumulating evidence that high tumor mutation load, which means there are high numbers of gene mutations in the tumor, can provide a signal to activate immune response systems thus rendering tumors more sensitive to immunotherapy.

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HPV Status Influences Survival in Esophageal Cancer

MedicalResearch.com Interview with:

Barrett's Esophagus -wikipedia

Barrett’s Esophagus -wikipedia

Shan Rajendra MBBCh, MSc , MD, FRCP, FRACP
Professor of Medicine
University of New South Wales
Director of Medicine & Clinical Executive Director
Bankstown-Lidcombe Hospital
Director Gastro-Intestinal Viral Oncology Group
Ingham Institute for Applied Medical Research
Sydney 

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

Response: High-risk human papillomavirus(HPV)  infection has been strongly associated with a subset of Barrett’s dysplasia and oesophageal adenocarcinoma.

The research question was; Does HPV status of Barrett’s high-grade dysplasia and esophageal adenocarcinoma influence survival as in viral positive head and neck cancers?

We therefore sought to determine the prognostic significance of esophageal tumor HPV status and associated viral transcriptional markers (E6/E7 mRNA and p16INK4A) and TP53.

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Bariatric Surgical Approach To Increase Bile Acids May Reduce Cocaine Reward

MedicalResearch.com Interview with:

Aurelio Galli, Ph.D. Professor of Molecular Physiology & Biophysics and Psychiatry & Behavioral Science Associate Director for Research Strategy Vanderbilt Brain Institute

Dr. Galli

Aurelio Galli, Ph.D.
Professor of Molecular Physiology & Biophysics and Psychiatry & Behavioral Science
Associate Director for Research Strategy
Vanderbilt Brain Institute

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

Response: The study builds on evidence that bile acids influence the brain’s reward system. Bile acids are normally released from the gall bladder into the upper part of the small intestine, where they emulsify fats for absorption, before being recycled further down the small intestine. In bile diversion surgery, an experimental treatment for weight loss, bile is released at the end of the small intestine, increasing the amount of bile acids that enter the general circulation.

Mice treated with this surgery have less appetite for high-fat foods, which suggests that bile acids affect brain reward pathways.

We demonstrated that mice receiving the surgery also showed less preference for the cocaine-associated chamber, indicating that cocaine was probably less rewarding. Continue reading

Both Honey and Carafate® May Slow Damage to Esophagus from Button Battery Ingestion

MedicalResearch.com Interview with:

“button battery of Apple Remote” by tsurutakoji is licensed under CC BY 2.0

Example of Button Battery

Kris R. Jatana, MD, FAAP, FACS
Associate Professor
Director, Pediatric Otolaryngology Quality Improvement
Department of Otolaryngology-Head & Neck Surgery
Nationwide Children’s Hospital & Wexner Medical Center
at Ohio State University

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

Response: More than 2,500 pediatric button battery ingestions occur annually in the United States. When lodged in the esophagus, rapid injury can occur from the tissue and saliva connecting the circuit of the battery. Serious injury can occur in a matter of hours. This results in a highly alkaline caustic injury that dissolves tissue, a process called liquefactive necrosis. There was a need for novel mitigation strategies to slow the progression of esophageal injury caused by presence of a button battery. This study aimed at identifying a palatable liquid that can be given at home or hospital setting to reduce esophageal injury until the battery can be removed. Continue reading

Developing a Pill That Mimics Effects of Gastric Bypass Surgery

MedicalResearch.com Interview with:

Jeff Karp B.Eng. PhD. Professor of Medicine Center for Nanomedicine and Division of Engineering in Medicine Brigham and Women’s Hospital, Harvard Medical School Boston MA

Prof. Karp

Jeff Karp B.Eng. PhD.
Professor of Medicine
Center for Nanomedicine and Division of Engineering in Medicine
Brigham and Women’s Hospital
Harvard Medical School
Boston MA

MedicalResearch.com: How would you briefly explain the most important findings and conclusions of this study to a non-expert?

  • The type-2 diabetes (T2D) epidemic will affect over 642 million people worldwide by 2040. As a result, diabetes costs the US healthcare over $174 billion dollars annually and is the leading cause of blindness, amputations, renal failure, and poor cardiovascular outcomes. Recently, bariatric surgery, bypassing stomach and intestine from the food stream, has shown promising results and shown to be superior to pharmaceuticals in managing T2D. However, the risks of surgery along with permanent changes to gastrointestinal anatomy deters many suitable patients from surgery, with less than 1-2% of Americans who qualify for weight loss surgery actually undergoing the procedure. Therefore, there is an urgent need for a safe, non-invasive and effective treatment for wider diabetic patient population.
  • We envisioned a pill that a patient can take before a meal that transiently coats the gut to replicate the effects of surgery. During the past 8 years, we’ve been working on this idea and have developed a safe gut-coating material that can potentially mimic the beneficial effects of gastric bypass procedures in the form a pill.
  • LuCI can be activated in any part of gastrointestinal tract (e.g. stomach, duodenum, intestine, colon) to form a temporary physical barrier that isolates that part of gastrointestinal tract. In our pre-clinical models, LuCI coated the duodenum to modulate glucose responses in oral glucose tolerance tests.
  • These beneficial effect are observed without any evidence of systemic absorption of the drug.
  • We believe that LuCI could be a new therapeutic approach for T2D that is based on Roux-en-Y gastric bypass surgery, but is safer, associated with significantly less complications, and thus can potentially help a wide T2D patient population.
  • In a separate set of studies, we also showed that luCi allows delivery of certain proteins and drugs, which would normally be degraded by the gastric acid, to the GI tract, protecting it from gastric acid digestion and prolonging their luminal exposure.

Continue reading

Amgen Tests IL-Blocker To Treat Symptoms of Hidden Gluten Consumption in Celiac Disease

MedicalResearch.com Interview with:

Markku Mäki, MD, PhD Professor (emeritus) at the University of Tampere and Presently research director at the Tampere University Hospital Tampere, Finland

Prof. Mäki

Markku Mäki, MD, PhD
Professor (emeritus) at the University of Tampere and
Presently research director at the
Tampere University Hospital
Tampere, Finland

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

Response: The only treatment for this life-long gluten-induced autoimmune systemic disease is a strict avoidance of wheat, rye and barley, the food cereals which contain gluten, the environmental trigger and driving force in celiac disease.  Gluten causes intestinal
inflammation, usually with (but sometimes without) gastrointestinal or
nutritional symptoms or signs, and with frequent extra-intestinal
diseases. However, it is impossible for celiac disease patients to
avoid gluten entirely and indefinitely and a third of patients report
symptoms on a strict gluten-free diet. Gut mucosal healing is not
optimal in half of the patients, and inflammation and injury is
detected for years after starting the diet, presumably due to
contamination with gluten in the diet. This is why patients are
requesting, and academia and industry are looking for novel adjunct
therapies for celiac disease. Initially, these therapies are tested to
prevent the consequences of hidden gluten; the ultimate goal being
that also celiacs could one day eat safely wheat, barley and rye
products. Some 20 novel experimental therapies are at present actively
being investigated (modifying wheat or different drugs, devices and
vaccines/immunotherapy).

The present study investigated whether blocking interleukin 15, an
important mediator of celiac disease, reduces or prevents
gluten-driven ill health, both the inflammation and injury at the
small intestinal mucosal level and gluten-induced symptoms. The
experimental drug used was Amgen’s AMG 714, a human monoclonal
antibody, used at a low and high dose, in the presence or absence of a
high-dose gluten challenge. Continue reading

Marked Increase in Colorectal Cancer in Teenagers and Younger Adults

MedicalResearch.com Interview with:

Anas Raed,MD Section of General Internal Medicine Augusta University

Dr. Raed

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.

Continue reading

More Than Half of Surveyed Chronic Pain Patients Report Opioid-Induced Constipation

MedicalResearch.com Interview with:

Dr. Joseph Pergolizzi MD Senior Partner and Director of Research Naples Anesthesia and Pain Associates Naples, Florida Adjunct Assistant Professor Johns Hopkins University School of Medicine Baltimore, Maryland

Dr. Pergolizzi

Dr. Joseph Pergolizzi MD
Senior Partner and Director of Research
Naples Anesthesia and Pain Associates
Naples, Florida

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

Response: There are roughly 100 million Americans living with chronic pain and many battle debilitating side effects because of their pain medication, including Painstipation otherwise known as opioid-induced constipation (OIC.) In fact, OIC is the most common side effect with approximately 40-80 percent of patients on chronic opioid therapy experiencing it.

To better understand this community, the Painstipation survey, conducted by Salix Pharmaceuticals in partnership with the U.S. Pain Foundation, surveyed 441 U.S. adults with chronic pain who were on opioid therapy and suffering from OIC. It gave great insight into this community as it found:

  • More than half (51 percent) of chronic pain patients have been suffering from opioid-induced constipation  for three years or longer
  • Most patients (73 percent) agree that one of the biggest challenges of having OIC is that medications don’t work quickly enough to relieve pain associated with OIC.
  • 53 percent of patients say they want relief for OIC in under four hours
  • Only half of patients surveyed (73 percent) surveyed said they were informed by their doctors that taking opioid medications might result in constipation before they began taking them
  • 77 percent of respondents reported suffering from OIC for at least one year
  • When asked, roughly one-third (32 percent) of patients reported that their doctor does not talk to them specifically about potential adverse drug-to-drug interactions (DDI) of their current prescription and/or over-the-counter medications.

Continue reading

DPP-4 inhibitor Class of Diabetes Medications Linked To Increase Risk of Inflammatory Bowel Disease

MedicalResearch.com Interview with:
Devin Abrahami,
graduate student
Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal
Department of Epidemiology, Biostatistics, and Occupational Health
McGill University, Montreal, QC, Canada

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

Response: The goal of our study was to assess whether a class of antidiabetic drugs, the dipeptidyl peptidase-4 (DPP-4) inhibitors, is associated with the risk of inflammatory bowel disease (IBD). While these drugs control blood sugar levels in patients with type 2 diabetes, there is some evidence that they may also be involved in immune function, and possibly in conditions such as IBD.

In our study, we found that the use of DPP-4 inhibitors was associated with a 75% increased risk of IBD, with the highest risk observed after three to four years of use. Continue reading

Salivary Peptide Protects Against E. Coli Diarrhea

MedicalResearch.com Interview with:

Esther Bullitt, Ph.D. Associate Professor Dept. of Physiology & Biophysics Boston University School of Medicine Boston, MA  02118-2526

Dr. Bullitt

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.   Continue reading

Adding Blood Biomarker To Ultrasound Improves Liver Cancer Detection

MedicalResearch.com Interview with:

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

Dr. Amit Singal

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. Continue reading

Liquid Biopsy Results for Cancer Mutations May Differ – Study Compares Idylla platform vs to OncoBEAM RAS CRC assay

MedicalResearch.com Interview with:

Dr. Ana Vivancos, Principal Investigator Cancer Genomics Group Vall d'Hebron Institute of Oncology (VHIO Barcelona 

Dr. Ana Vivancos

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%).

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Probiotics May Help Colic in Breastfed But Not Formula Fed Babies

MedicalResearch.com Interview with:

Dr Valerie Sung MBBS (Hons) FRACP MPH PhD Department of Paediatrics The University of Melbourne Murdoch Childrens Research Institute Parkville, Australia

Dr. Sung

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.

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GERD Associated With Increased Risk of Malignancy of the Upper Aerodigestive Tract

MedicalResearch.com Interview with:

Dr. Edward D. McCoul, MD, MPH Ochsner Medical Center

Dr. McCoul

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.

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Capsule Fecal Transplant As Effective as By Colonoscopy for C. Diff Infections

MedicalResearch.com Interview with:

Clostridium difficile CDC image

Clostridium difficile
CDC image

Dina Kao, MD, FRCPC
Division of Gastroenterology, Department of Medicine
University of Alberta
Edmonton, Alberta, Canada

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

Response: We wanted to see what would be the best way to deliver fecal microbiota transplantation (FMT.)

There were many controlled studies of FMT delivered by various methods, showing different success rates. Not only were the route of delivery different, but the amount of donor stools also varied greatly from study to study. It appeared that most of the studies delivered by the upper routes gave a smaller amount of donor stool compared to the studies delivering FMT by colonoscopy.

Our hypothesis was that given the same amount of donor stool, the effectiveness would be similar by capsules and by colonsocopy.

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Survey Finds Americans Routinely Ignore Over-the-Counter Pain Medication Labels

MedicalResearch.com Interview with:

Charles Melbern (Mel) Wilcox, MD, MSPH Director of the division of Gastroenterology and Hepatology University of Alabama-Birmingham

Dr. Wilcox

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).

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IQuity Releasing First RNA-Based Blood Test for Inflammatory Bowel Disease

MedicalResearch.com Interview with:
Iquity IncChase 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.  Continue reading

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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