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Search / Trial NCT06433180

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 February 08, 2025

Not yet recruiting

Keywords

Fecal Microbiota Transplantation Irritable Bowel Syndrome Frozen Capsule Rome Iv Ibs Sss

ClinConnect Summary

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 ...

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)

Trial Officials

Jean Marc SABATE, Pr

Study Director

Assistance Publique - Hôpitaux de Paris

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.

Locations

Bobigny, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0