Impact of Fecal Microbiota Transplantation in Ulcerative Colitis

NCT03483246 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: P 160931J2017-003802-42
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts. The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Inflammatory bowel disease; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Steroid-free clinical and endoscopic remission

  Steroid-free clinical and endoscopic remission defined as a total Mayo score of 2 or lower and no subscore higher than 1 and mucosal healing defined as an endoscopic subscore of 0 or 1 (Sigmoidoscopy).

  12 weeks after FMT or sham-transplantation

Secondary Outcomes (11)

• Steroid-free clinical remission

  12 weeks after FMT or sham-transplantation

• Steroid-free clinical remission

  24 weeks after FMT or sham-transplantation

• Steroid-free endoscopic response

  12 weeks after FMTor sham-transplantation

• Steroid-free endoscopic remission

  12 weeks after FMT or sham-transplantation

• Microbiota composition and diversity

  12 and 24 weeks after FMT or sham-transplantation

Study Arms (2)

Group B - fecal microbiota transplantation

EXPERIMENTAL

Patients receiving the fecal microbiota transplantation (FMT) in 3 times after inclusion and randomisation

Drug: Fecal Microbiota Transplantation (FMT)

Group A- Sham-transplantation

PLACEBO COMPARATOR

Patients receiving the sham-transplantation in 3 times after inclusion and randomisation

Drug: Sham-transplantation Placebo

Interventions

Fecal Microbiota Transplantation (FMT) DRUG

The colonoscopy for FMT will be planned as soon as possible and never more than 5 weeks after inclusion visit. After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of physio, see donor section for details) or sham transplantation (FMT vehicle) in the cecum.

Group B - fecal microbiota transplantation

Sham-transplantation Placebo DRUG

The sham-transplantation will be planned as soon as possible and never more than 5 weeks after inclusion visit. After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia. The patient will then sham transplantation (FMT vehicle) in the cecum.

Group A- Sham-transplantation

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \< 75 years
• Ulcerative colitis (according to the Lennard Jones criteria) diagnosed for at least 3 months and :
• Currently active (PMC \> 1) and planned to be treated by systemic corticosteroids (minimum 40mg prednisone equivalent daily) Or
• Currently treated by systemic corticosteroid (minimum 40 mg prednisone equivalent daily) within max 3 weeks Or
• Patient with health insurance (AME excepted)
• Informed written consent
• Female of child-bearing age with an active contraception and this during at least period of treatment until the end of active follow-up period (week 24)
• Age ≥ 18 years and \< 50 years
• kg/m² \< body mass index \< 30 kg/m²
• Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
• Subject with health insurance (AME excepted)
• Informed Written consent

You may not qualify if:

• UC complication requiring surgical treatment
• Contraindication to colonoscopy or anesthesia
• Pregnancy or breastfeeding during the study
• Treatment preceding the colonoscopy with:
• intravenous infliximab and/or vedolizumab and/or ustekinumab (\< 6 weeks before the planned date of the colonoscopy) and/or subcutaneous infliximab (\<2 weeks before the planned date of the colonoscopy), and /or adalimumab (\<2 weeks before the planned date of the colonoscopy) and/or golimumab and/or tofacitinib (\<4 weeks before the planned date of the colonoscopy)
• immunosuppressant (thiopurine, methotrexate, tacrolimus or other classical immunosuppressant) started or stopped \< 3 months before the planned date of the colonoscopy
• Antibiotics, antifungic or probiotics treatment \< 4 weeks before the planned date of the colonoscopy
• participation in any other interventional study
• patient under legal protection
• \- For details, please see protocol.

Sponsors & Collaborators

• CRB-HUEP: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Service de Gastroentérologie et Nutrition Hôpital Saint Antoine

Paris, Paris, 75012, France

Location

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MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Harry SOKOL, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 30, 2018
• Study Start: September 17, 2018
• Primary Completion: September 16, 2025
• Study Completion (Estimated): March 27, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)