Informations générales (source: ClinicalTrials.gov)
A Prospective, Multi-center, Double Blind Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule Versus Placebo in Severe Irritable Bowel Syndrome (IBS). (ICEBOAT)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2024
juillet 2029
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Jean MARC SABATE, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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)