Taking people in FrancePhase 3
Study of Fecal Microbiota Transplantation (FMT) in Severe IBS Patients
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Bobigny, Clermont-Ferrand, Colombes Cedex, Lyon, Marseille, Pessac, Rennes Cedex 9, and Rouen, FranceSee the 8 sites
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 150 people, planned
- Started
- 1 Jul 2025
- Expected to end
- 15 Jul 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Administration of fecal microbiota transplantation ( FMT capsules)
- Administration of the sham (PLACEBO)
- Record updated
- 27 June 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Surgical intervention in the gastrointestinal region except for appendectomy, hernia repair, cholecystectomy and hemorroidectomy
- Abuse of alcohol or drugs
- Presence of systemic disease, immune deficiency or treatment with immune-modulators
- Other chronic gastrointestinal disease (celiac disease, inflammatory bowel disease)
- Acute COVID-19 infection
- Severe psychiatric disorder
- participants if there is a reason to suspect an alternative diagnosis to the IBS complaints
- Treatment preceding FMT with: antibiotics, antifungic or probiotics treatment < 4 weeks, or factors that may affect the composition of intestinal microbiota
- Pregnancy or breastfeeding
- Participation in any other interventional study
- Patients under legal protection
- Participants who were assessed as likely to be noncompliant (ie, not adhering to the tasks they were to perform as participants)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in France
- Assistance Publique Hopitaux De ParisBobigny, FranceTaking people
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranceTaking people
- Assistance Publique Hopitaux De ParisColombes Cedex, FranceTaking people
- Hospital Edouard HerriotLyon, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Centre Hospitalier Universitaire De RennesRennes Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire RouenRouen, FranceTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Administration of the sham (PLACEBO)Placebo, for comparison
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.
- Administration of fecal microbiota transplantation ( FMT capsules)Treatment being tested
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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).
- Fit questions
- Built from NCT06433180, who can take part
- Record updated
- 27 June 2025