Study of Fecal Microbiota Transplantation (FMT) in Severe IBS Patients

NCT06433180 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: APHP1805832019-003433-41
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

fecal microbiota transplantation; irritable bowel syndrome; frozen capsule; Rome IV; IBS-SSS

Outcome Measures

Primary Outcomes (1)

• Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS.

  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.

  At 12 weeks

Secondary Outcomes (10)

• Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 50 points decrease in IBS-SSS.

  At 12 weeks

• FMT success

  At 12 weeks

• Intestinal microbiota composition at week 12 and 24 by 16s sequencing.

  at week 12 and 24

• Efficacy (decrease in IBS severity >75 points) at week 24 according to FMT success.

  At 24 weeks

• EMA Endpoint at week 12 and 24 defined as a patient who fulfils the response criteria (simultaneous improvement of transit and abdominal pain) displayed in the following for at least 50% of the observation time.

  at week 12 and 24

Study Arms (2)

Administration of the sham (PLACEBO)

PLACEBO COMPARATOR

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.

Drug: Administration of the sham (PLACEBO)

Administration of fecal microbiota transplantation ( FMT capsules)

EXPERIMENTAL

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.

Drug: Administration of fecal microbiota transplantation ( FMT capsules)

Interventions

Administration of fecal microbiota transplantation ( FMT capsules) DRUG

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 fecal microbiota transplantation ( FMT capsules)

Administration of the sham (PLACEBO) DRUG

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 the sham (PLACEBO)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Gastro-enterology department, Avicenne Hospital

Bobigny, 93000, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jean Marc SABATE, Pr

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Jean Marc SABATE, Pr

CONTACT

01 48 95 54 34; jean-marc.sabate@aphp.fr

Nacira DARGHAL, PhD

CONTACT

01 48 95 74 73; nacira.darghal@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 29, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2029
• Last Updated: June 27, 2025

Record last verified: 2025-05

Locations

FR (1)