Study of Fecal Microbiota Transplantation (FMT) in Severe IBS Patients
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 26, 2024
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) to see if it can help people with severe irritable bowel syndrome (IBS) who haven't found relief from other treatments. In this trial, participants will receive either oral capsules containing frozen stool from healthy donors or a placebo (fake treatment) for 12 weeks. The researchers want to know if this treatment can reduce the severity of IBS symptoms.
To be eligible for this study, participants must be between 18 and 75 years old and have been diagnosed with severe IBS that hasn't improved after trying at least two different treatments, such as medications or special diets. Participants will need to provide informed consent and, if they're women of childbearing age, use effective contraception during the study. This trial is not yet recruiting participants, but it aims to provide valuable insights into a new potential treatment for those struggling with severe IBS.
Gender
ALL
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)
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bobigny, , France
Patients applied
Trial Officials
Jean Marc SABATE, Pr
Study Director
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported