Menu
Not yet recruiting NCT06433180

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

Phase III Interventional Irritable Bowel Syndrome

For patients and families

In plain language

Fill the application

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Administration of fecal microbiota transplantation ( FMT capsules), Administration of the sham (PLACEBO).
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multi-center, Double Blind Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule Versus Placebo in Severe Irritable Bowel Syndrome (IBS).

Overview

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.

Detailed 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.

Interventions

  • Drug Administration of fecal microbiota transplantation ( FMT capsules)
    Oral, capsulized, frozen fecal microbiota transplantation FMT delivering approximatively 24 g of stools taken in one day in two separate meals. Administration of the FMT after colon cleaning.
  • Drug Administration of the sham (PLACEBO)
    Oral, capsulized, frozen capsules without fecal matter but containing cryopreservation solution will be administered at the same volume and same time point as in the experimental group. Taken in one day in two separate meals. Administration of the sham after colon cleaning.

Primary outcome measures

  • Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS. [Time frame: At 12 weeks]
Secondary outcome measures (10)
  • Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 50 points decrease in IBS-SSS. [Time frame: At 12 weeks]
  • FMT success [Time frame: At 12 weeks]
  • Intestinal microbiota composition at week 12 and 24 by 16s sequencing. [Time frame: at week 12 and 24]
  • Efficacy (decrease in IBS severity >75 points) at week 24 according to FMT success. [Time frame: At 24 weeks]
  • EMA Endpoint at week 12 and 24 defined as a patient who fulfils the response criteria (simultaneous improvement of transit and abdominal pain) displayed in the following for at least 50% of the observation time. [Time frame: at week 12 and 24]
  • Percentage of responders in the different subgroups IBS-D, IBS-C and IBS-M using the primary endpoint at week 12 and 24. [Time frame: at week 12 and 24]
  • Mean IBS-SSS (IBS severity), comparison between FMT and placebo at 12 and 24 weeks) [Time frame: at week 12 and 24]
  • Mean IBS-QoL score (IBS Quality of life) comparison between FMT and placebo at 12 and 24 weeks (Drossman et al. 2000) [Time frame: at week 12 and 24]
  • Patient's perception of FMT : - Questionnaire for correct assessment of FMT or placebo and FMT acceptability) at V2 (FMT administration). - Questionnaire for assessment of FMT secondary effects at V3. [Time frame: V2: five weeks after inclusion. V3:Four weeks after V2]
  • Safety (Serious Adverse Events, Adverse Events) compared between groups. [Time frame: through study completion, at 24 months]

Eligibility criteria

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 treatment strategies:among the following : anti-spasmodic and/or laxatives (polyethylene glycol) or anti-diarrheal drug (loperamide) according to transit subtype for one month, antidepressants for 2 months, probiotics (ALFLOREX, SMEBIOCTA, PROBIOLOG FLORVIS) for 1 month, hypnosis for 5 hypnosis sessions in two months, Cognitive Behavioral 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 in IBS-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 physical activity.
  • Patient with health insurance (AME excepted)
  • Informed written consent
  • For women with childbearing potential, efficient contraception for the duration of the participation to the study

Exclusion criteria

  • Other chronic gastrointestinal disease (celiac disease, inflammatory bowel disease)
  • participants if there is a reason to suspect an alternative diagnosis to the IBS complaints
  • Surgical intervention in the gastrointestinal region except for appendectomy, hernia repair, cholecystectomy and hemorroidectomy
  • Treatment preceding FMT with: antibiotics, antifungic or probiotics treatment < 4 weeks, 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 the tasks they were to perform as participants)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Gastro-enterology department, Avicenne Hospital — Bobigny

Identifiers

NCT: NCT06433180 · APHP180583 · 2019-003433-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗