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Irritable Bowel Syndrome clinical trials

View clinical trials related to Irritable Bowel Syndrome.

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NCT ID: NCT02154867 Completed - Clinical trials for Irritable Bowel Syndrome

Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial.

REFIT
Start date: December 2014
Phase: Phase 2
Study type: Interventional

Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial - the REFIT project Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of life and increased sickness absence. The prevalence of IBS in the general population may be as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other less well founded theories have been stated. So far, no measurement or test can affirm diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern according to the Rome classification can set the diagnosis. Earlier non-controlled case reports have shown a convincing effect of fecal microbial transplantation (FMT) in IBS patients. However, no placebo controlled trial has been performed in this condition. Changes in the gut microbiome may be an important factor in IBS pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may trigger changes in visceral sensibility and pain perception. The fecal microbial transplantation (FMT) procedure has been used primarily to treat clostridium difficile infections. Few minor side effects have been reported. Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by transplanting a microbiome sample from a healthy donor. Aim of study: - To test the clinical effect of FMT in patients with IBS - To describe the fecal microbiome in IBS patients - To describe changes in the fecal microbiome of IBS patients following FMT The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients will recruited from general practice and allocated to active (30) or placebo (30) by block randomization. Donors will be 15 healthy volunteers with no risk behaviour and a pre-screening for communicable diseases will be performed. Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0, 1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.

NCT ID: NCT02144753 Terminated - Clinical trials for Constipation-predominant IBS (IBS-C)

Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)

Start date: March 2014
Phase: Phase 2
Study type: Interventional

The objective of this Phase II trial is to test the NTX-1 Fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. The investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e has less side effects) and is more effective than psyllium (the most commonly used fiber in the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA levels.

NCT ID: NCT02136745 Completed - Clinical trials for Irritable Bowel Syndrome

Effects of Relaxation Response Mind-body Intervention in Patients With IBS and IBD

Start date: May 2009
Phase: N/A
Study type: Interventional

In this pilot study, the investigators examined whether a relaxation response mind-body intervention could be effectively delivered to mixed groups of IBS and IBD patients and determined the effects of the intervention on quality of life, inflammatory markers, and gene expression using transcriptional profiling.

NCT ID: NCT02120027 Terminated - Clinical trials for Irritable Bowel Syndrome With Diarrhea

52-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)

IRIS-4
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 24-week treatment period

NCT ID: NCT02113605 Completed - Clinical trials for Functional Dyspepsia

Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders

CBT
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

NCT ID: NCT02113111 Completed - Clinical trials for Cardiovascular Diseases

Effects of Fasting on Self Efficacy

TheraFast
Start date: April 2014
Phase: N/A
Study type: Observational

The study aims to investigate - if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with chronic diseases - the effects of fasting on physical and mental well-being, quality of life and body awareness/image - the association between patients characteristics and the perceived health benefit after fasting - the association between Diagnosis according to traditional Chinese medicine and physical and mental well-being during the course of fasting - experiences and perceptions of patients during fasting therapy

NCT ID: NCT02111603 Completed - Clinical trials for Diarrhea Predominant Irritable Bowel Syndrome

Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids

Start date: April 2014
Phase: Phase 4
Study type: Interventional

The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.

NCT ID: NCT02108119 Completed - Clinical trials for Irritable Bowel Syndrome

The Effect of Probiotics on Symptoms and Intestinal Flora in Patients With Irritable Bowel Syndrome

Start date: May 2, 2014
Phase: Phase 2
Study type: Interventional

To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.

NCT ID: NCT02107625 Completed - Clinical trials for Irritable Bowel Syndrome

Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients

KRIBS
Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.

NCT ID: NCT02107196 Completed - Clinical trials for Irritable Bowel Syndrome With Diarrhea

12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)

IRIS-3
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.