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

MedicalResearch.com Interview with:

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

Dr. Cash

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

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

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

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

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

MedicalResearch.com Interview with:

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

Prof. Camilleri

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

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

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

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

MedicalResearch.com Interview with:

Bradley James Ferguson, PhD University of Missouri School of Medicine

Dr. Ferguson

Bradley James Ferguson, PhD
University of Missouri School of Medicine 

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

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

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

MedicalResearch.com Interview with:

Sahil Khanna,

Dr. Sahil Khanna

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

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

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

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

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Investigational Compound Improves Gut Microbiome Without Long-Term GI Symptoms

MedicalResearch.com Interview with:

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

Dr. Fernando Azpiroz

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

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

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

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

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

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ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries

MedicalResearch.com Interview with:

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

Dr. Paul Y. Kwo

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

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

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

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

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How Do Patients Decide Among Biologics for Inflammatory Bowel Disease?

MedicalResearch.com Interview with:

Christopher V. Almario, MD, MSHPM</strong> 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

Dr. Christopher V. Almario

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.

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DRD2 Inhibitors As Potential Therapy Against Pancreatic Cancer

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.
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Ingestible Sensor Demonstrates Positive Effects of Cinnamon

MedicalResearch.com Interview with:

Distinguished Professor Kourosh Kalantar-zadeh RMIT's School of Engineering Australia

Prof. Kourosh Kalantar-Zadeh

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.

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Rubber Band vs Artery Ligation Surgery for Hemorrhoids Compared

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

Mr. Steven Brown

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.

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Phase 2 Trials of Methane Inhibitor Improved Symptoms of Irritable Bowel Syndrome

MedicalResearch.com Interview with:

Mark Pimentel, MD Associate Professor, Medicine Director, GI Motility Program Director, GI Motility Laboratory Cedars-Sinai

Dr. Mark Pimentel

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.

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Vanderbilt Free Colonoscopies For Uninsured Detected Some Early Cancers and Was Cost Neutral

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.

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Bacterial Alterations Precede Necrotising Enterocolitis In Low Birthweight Infants

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.

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Irritable Bowel Symptoms Reduced By Antihistamine

Prof. Guy Boeckxstaens Translational Research in GastroIntestinal Disorders KU Leuven, Belgium

Prof. Guy Boeckxstaens

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.

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Split Bowel Prep For Colonoscopy Results In More Polyps Detected

Dr Franco Radaelli Division of Digestive Endoscopy and Gastroenterology Valduce Hospital Como, Italy

Dr. Franco Radaelli

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.

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Skin Problems Common With anti-TNF therapy For IBD

Isabelle Cleynen PhD University of Leuven

Dr. Cleynen

MedicalResearch.com Interview with:
Isabelle Cleynen  PhD

University of Leuven 

Medical Research: What is the background for this study? What are the main findings?

Dr. Cleynen : Ulcerative colitis and Crohn’s disease, together inflammatory bowel disease (IBD), are characterized by chronic inflammation of the gastrointestinal tract. Treatment for IBD usually involves drug therapy including anti-inflammatory drugs and immune system repressors, amongst which biologics as the anti-TNF antibodies used for patients with moderate to severe IBD. Although these TNF-blocking drugs are effective in many patients with immune-mediated disorders like psoriasis, rheumatoid arthritis and spondylarthropathies, and IBD, several case reports and series showed that some patients developed troubling skin problems (including psoriasis and eczema), causing them to stop the anti-TNF treatment. It is however not clear how often these skin problems develop in IBD patients treated with anti-TNF, and what could be the predisposing factors.

In a retrospective cohort of 917 IBD patients initiated on anti-TNF therapy in a single center, we have studied which patients did and did not develop skin problems, what type of skin problems, how they were treated, and whether the lesions resolved upon treatment.

We found that about one third of the patients developed skin problems while being treated with anti-TNF drugs. The most common type was psoriasiform eczema, often occurring in flexural regions, the scalp, and genitalia. The time between starting the TNF-blocking drug and the appearance of the skin problem varied from less than half a year to more than 4 years. Quite surprisingly, we found that the cumulative dose of the treatment, or drug serum levels were not different in skin and non-skin lesion patients. Skin lesion patients however seemed to be younger when diagnosed with IBD and when started on anti-TNF agents, more often had anti-nuclear and dsDNA antibodies (both auto-immune factors), and a higher number of skin-disease related genetic risk variants. Most patients had a good response to treatment of their skin problem. About 10% of the patients who developed skin problems, however, stopped the TNF-blocking treatment because of this issue.

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