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Irritable Bowel Syndrome clinical trials

View clinical trials related to Irritable Bowel Syndrome.

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NCT ID: NCT03763175 Terminated - Clinical trials for Irritable Bowel Syndrome With Constipation

Efficacy and Safety of SYN-010 in IBS-C

Start date: December 24, 2018
Phase: Phase 2
Study type: Interventional

Irritable bowel syndrome (IBS) is a gastrointestinal (GI) syndrome characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. The symptoms of IBS not only adversely affect a patient's health-related quality of life (QoL), but also place a significant financial burden on society due to reduced work productivity and increased use of healthcare-related resources. Patients with IBS frequently complain of abdominal bloating and increased gas production in the form of flatulence or belching. The prevalence in North America and Europe is approximately 10-15%. Irritable bowel syndrome affects all ages and genders however there is a 2:1 female predominance in North America. Irritable bowel syndrome is classified into 4 subtypes based on stool pattern: IBS with constipation (IBS-C), IBS with diarrhea, mixed IBS, and un-subtyped IBS. Irritable bowel syndrome with constipation is defined as the presence of hard or lumpy stools with ≥ 25 percent of bowel movements and loose or watery stools with < 25% of bowel movements. SYN-010 is a modified release, oral formulation of lovastatin being developed for the treatment of IBS-C. The SYN-010 program is based predominantly on research by Dr. Mark Pimentel and collaborators hypothesizing that reduction in intestinal methane (methane) production can reverse constipation and improve global symptoms in IBS-C. Methane production in humans is due to methanogenic archaea in the intestine, predominantly Methanobrevibacter smithii (M. smithii). Methane, the key product of anaerobic respiration of methanogens, had been perceived to produce no ill effects in humans aside from gaseous distention. However, several research groups worldwide have shown that a significant percentage of patients with IBS-C excrete methane, and elevated methane production by methanogens correlates with constipation and related symptoms in both IBS-C and chronic idiopathic constipation. A direct causative role for methane in IBS-C was demonstrated in a recent case report, wherein a woman undergoing fecal microbiota transplantation (FMT) for C. difficile infection unknowingly received stool containing a high concentration of methanogens. The FMT recipient rapidly developed severe symptoms of IBS-C that were subsequently reversed by ablation of methane production.

NCT ID: NCT03462966 Terminated - Clinical trials for Irritable Bowel Syndrome

Rifaximin on Visceral Hypersensitivity

Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a global prevalence of 11% according to a recent meta-analysis. The total cost of managing IBS in the United States is in excess of $30 billion per year, including indirect costs relating to loss of productivity of more than $20 billion. Abdominal pain/discomfort (i.e. visceral hypersensitivity) is present in all patients with IBS and remains the most therapy-resistant symptom. Apart from abdominal pain, which is measured subjectively using visual scales, several studies have shown a significant increase in rectal sensitivity, which is measured objectively using an inflatable balloon. Drugs which are shown to have objective effects on visceral hypersensitivity are crucial in the management of IBS. While certain drugs have shown to decrease abdominal pain, there is very little data to substantiate objective changes in visceral hypersensitivity. Rifaximin is a poorly absorbed antibiotic and the exact underlying mechanism of action for rifaximin in reducing the pain component of IBS remains unknown. However, rifaximin has been shown in randomized controlled trials to decrease abdominal discomfort in all subtypes of IBS. The investigators hypothesize that rifaximin is effective in decreasing rectal visceral hypersensitivity in IBS patients. In this study, the investigators propose to test this hypothesis by measuring visceral hypersensitivity using the graded balloon distention test, before and after a course of rifaximin. To test whether this effect is accompanied by treating SIBO, the investigators will also perform lactulose breath tests before and after rifaximin therapy.

NCT ID: NCT03336034 Terminated - Clinical trials for Constipation-predominant Irritable Bowel Syndrome

Assessment of Responsiveness to Treatment by Experience Sampling Method

Start date: January 1, 2018
Phase:
Study type: Observational

Reliable evaluation of symptoms and their improvement during treatment is crucial in both diagnosing and evaluating response to treatment in IBS. Currently used end-of-day evaluations are considered sub-optimal and the Experience Sampling Method (ESM) was proposed previously as a more accurate symptom assessment method. Aim of this study is to evaluate the responsiveness of the developed ESM-PROM in assessing changes in abdominal pain and stool frequency after linaclotide treatment of IBS-C patients.

NCT ID: NCT03220711 Terminated - Adenomatous Polyps Clinical Trials

Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon

Start date: July 28, 2017
Phase: N/A
Study type: Interventional

The overall aim of this research project is to evaluate the imaging performance of a confocal endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group. This endomicroscope probe will be used during colonoscopies in subjects with colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).

NCT ID: NCT03148288 Terminated - Clinical trials for Irritable Bowel Syndrome

Vitamin D Supplementation in IBS

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) is a very common functional gastrointestinal disorder affecting nearly 20% of the North American population. IBS is characterized by chronic abdominal, associated with a change in bowel frequency and or consistency that lack a known structural or anatomic explanation. Current treatment for IBS is primarily symptom-based. However over a third of patients with IBS fail to respond to currently available therapies. The prevalence of vitamin D deficiency/insufficiency is estimated in over a billion people world-wide . Vitamin D has potential mechanisms not only in the balance of calcium and bone homeostasis, but also a key modulator of the immune system. Vitamin D receptors (VDRs) are located on all nucleated cells including the GI tract. Thus far, there is already accumulating evidence for a role for vitamin D supplementation in inflammatory bowel disease (IBD). A recent systematic review suggested there may be benefits of vitamin D supplementation in IBD. Vitamin D insufficiency is widespread in patients with IBS and there is a positive association between vitamin D status and quality of life. To date, there is no US trial examining the effect of vitamin d supplementation on IBS symptoms and quality of life in patients with IBS.

NCT ID: NCT02932111 Terminated - Clinical trials for Irritable Bowel Syndrome

Irritable Bowel Syndrome and Osteopathic Manipulative Therapy

IBSOMT
Start date: May 12, 2017
Phase: N/A
Study type: Interventional

The Irritable Bowel Syndrome (IBS) is defined by a combination of abdominal pain, bowel dysfunction during recurrent periods of shorter or longer duration. The absence of well-defined pathophysiological marker requires a clinical definition. The most used are the Rome criteria III whose version was published in 2006 and version IV under development. An epidemiological study conducted in 2003 in Europe in 8 countries with over 42 000 people, found on the basis of questionnaires a prevalence of 11.5% with a diagnosis of IBS of 4.8%.in the total population; the results of this study were comparable to data obtained in the USA. A French work of our team at 35 447 healthy adults found a 6.2% frequency. In all these studies, there is a very large predominance of women (sex ratio near 2), with a preponderance of subjects of the age group 40-50 years. IBS economic weight is high, partly due to costs directly incurred by the IBS and the costs generated by associated diseases: number of visits to the general practitioner, to the specialist, the prescription and realization of complementary examinations, hospitalization, purchase drugs and work stoppage. From a pathophysiologic perspective, IBS is now considered as a multifactorial disease involving varying degrees, depending on the individual variables, visceral hypersensitivity, disturbances of digestive motility, impaired sensorimotor way communications between the gastrointestinal tract and the central nervous system, intestinal micro-inflammation. Hypothesis of this search is that the osteopathic manipulative treatment (OMT) will improve the symptomatology of IBS in patients with functional gastrointestinal disorders.

NCT ID: NCT02837783 Terminated - Clinical trials for Irritable Bowel Syndrome Characterized by Constipation

A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

Start date: December 21, 2016
Phase: Phase 4
Study type: Interventional

The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.

NCT ID: NCT02559817 Terminated - Clinical trials for Irritable Bowel Syndrome With Constipation

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

LIN-MD-63
Start date: November 1, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

NCT ID: NCT02544152 Terminated - Clinical trials for Irritable Bowel Syndrome

Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

Start date: February 2015
Phase: Phase 2
Study type: Interventional

A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.

NCT ID: NCT02313246 Terminated - Clinical trials for Irritable Bowel Syndrome

A Pilot Study of Cognitive-Behaviour Therapy for Irritable Bowel Syndrome and the Gut Microbiome

IBS
Start date: August 2015
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of a group cognitive behaviour therapy for Irritable Bowel Syndrome (IBS) in decreasing symptoms of IBS, improving quality of life, and normalizing the gut microbiome. Patients will complete an 11-week group cognitive behaviour therapy for IBS within 1 month of being deemed eligible for the study.