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Clinical Trial Summary

The objective of this protocol is to evaluate the efficacy of fecal microbiota transplantation (FMT) using oral capsules containing frozen stools vs sham FMT on IBS severity score at 12 weeks in patients with severe irritable bowel syndrome refractory to conventional treatments.


Clinical Trial Description

Irritable bowel syndrome (IBS) is a chronic disease. It affects about 4.4 to 10 % of the French general population (according to Rome III or Rome IV definition) and is the most frequent functional bowel disorder in patients visiting general practitioners or gastroenterologists. The efficacy of treatments is often limited, in particular form the case severe of IBS (IBS-SSS>300) which concerns at least 20 to 25% of patients and IBS can cause significant deterioration in quality of life. In this context, microbiota could become a potential therapeutic target, and replacement of the abnormal fecal microbiota by an "healthy" one, especially in patients refractory to previous treatment and with severe symptoms, is a seducing new therapeutic strategy. The primary outcome is an improvement in the IBS-SSS score level at 12 weeks after taking a oral capsules of FMT in patients with severe IBS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06433180
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Jean Marc SABATE, Pr
Phone 01 48 95 54 34
Email jean-marc.sabate@aphp.fr
Status Not yet recruiting
Phase Phase 3
Start date June 1, 2024
Completion date July 15, 2029

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