Study of Fecal Microbiota Transplantation (FMT) in Severe IBS Patients

Last updated: June 24, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Not Recruiting

Phase

3

Condition

Colic

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

Administration of the sham (PLACEBO)

Administration of fecal microbiota transplantation ( FMT capsules)

Clinical Study ID

NCT06433180
APHP180583
2019-003433-41
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years and < 75 years

  • IBS defined according to Rome IV definition (IBS-C, IBS-D or IBS-M)

  • Severe disease (IBS-SSS >300) and refractory to at least two previous treatmentstrategies:among the following : anti-spasmodic and/or laxatives (polyethyleneglycol) or anti-diarrheal drug (loperamide) according to transit subtype for onemonth, antidepressants for 2 months, probiotics (ALFLOREX, SMEBIOCTA, PROBIOLOGFLORVIS) for 1 month, hypnosis for 5 hypnosis sessions in two months, CognitiveBehavioral Therapies for 2 months, colestyramine for IBS-D patients for 1 month,ondansetron for IBS-D patients and for 1 month, ebastine for 2 months, L-glutamine (5g x3/day, for 2 months, Gelsectan for one month, Biofeedback for 15 sessions inIBS-C (3 months), Low FODMAP diet for 1 month, gluten free diet for 1 month,standard dietary advice from the NICE (UK) for 1 month, increase in physicalactivity.

  • Patient with health insurance (AME excepted)

  • Informed written consent

  • For women with childbearing potential, efficient contraception for the duration ofthe participation to the study

Exclusion

Exclusion Criteria:

  • Other chronic gastrointestinal disease (celiac disease, inflammatory bowel disease)

  • participants if there is a reason to suspect an alternative diagnosis to the IBScomplaints

  • Surgical intervention in the gastrointestinal region except for appendectomy, herniarepair, cholecystectomy and hemorroidectomy

  • Treatment preceding FMT with: antibiotics, antifungic or probiotics treatment < 4weeks, or factors that may affect the composition of intestinal microbiota

  • Abuse of alcohol or drugs

  • Pregnancy or breastfeeding

  • Participation in any other interventional study

  • Patients under legal protection.

  • Acute COVID-19 infection

  • Presence of systemic disease, immune deficiency or treatment with immune-modulators

  • Severe psychiatric disorder

  • Participants who were assessed as likely to be noncompliant (ie, not adhering to thetasks they were to perform as participants)

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Administration of the sham (PLACEBO)
Phase: 3
Study Start date:
July 01, 2025
Estimated Completion Date:
July 15, 2029

Study 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.

Connect with a study center

  • Gastro-enterology department, Avicenne Hospital

    Bobigny, 93000
    France

    Site Not Available

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