Administration of fecal microbiota transplantation ( FMT capsules)Administration of the sham (PLACEBO)
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.
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.
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS. — At 12 weeks To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks in patients with irritable bowel syndrome with severe disease refractory to conventional treatments.
Decrease in IBS severity at 12 weeks is defined by the percentage of patients having at least a 75 points decrease in IBS-SSS.
Trial sites (1)
Facility
City
Region
Status
Gastro-enterology department, Avicenne Hospital
Bobigny
France
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
