Using fecal microbiota transplantation to treat ulcerative colitis

Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial

This study is testing whether a treatment that involves transferring healthy gut bacteria can help people with ulcerative colitis feel better after their usual treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Drugs / interventions: infliximab, vedolizumab, ustekinumab, adalimumab, golimumab, tofacitinib, methotrexate, prednisone
• Locations: 1 site (Paris)
• Trial ID: NCT03483246 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of fecal microbiota transplantation (FMT) on patients with ulcerative colitis (UC), a chronic inflammatory bowel disease. The research aims to determine whether transferring healthy gut microbiota can improve clinical outcomes in UC patients who are in remission after conventional treatments. The study includes both active UC patients and healthy volunteers who will provide fecal samples for transplantation. Participants will be monitored for 24 weeks to assess the efficacy and safety of the intervention compared to a sham-transplantation placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of ulcerative colitis who are currently active or steroid-dependent.

Not a fit: Patients with mild or inactive ulcerative colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with ulcerative colitis, potentially reducing reliance on conventional immunosuppressive therapies.

How similar studies have performed: Previous studies have shown promise in using fecal microbiota transplantation for other gastrointestinal conditions, but its application in ulcerative colitis is still being explored.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria for patients :

* 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
  * Steroid dependent patients (at least one unsuccessful attempt to discontinue steroid within the last 6 months before inclusion)
* 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)

Inclusion Criteria for healthy volunteers donors :

* Age ≥ 18 years and \< 50 years
* 17 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

Exclusion Criteria:

Exclusion Criteria for patients :

* UC complication requiring surgical treatment
* Patient treated with high dose corticosteroid more than three weeks before inclusion (≥ 40 mg prednisone equivalent daily) except in case of steroid-dependence
* 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

Exclusion Criteria for healthy volunteers donors :

- For details, please see protocol.

Where this trial is running

Paris

• Service de Gastroentérologie et Nutrition Hôpital Saint Antoine — Paris, France (RECRUITING)

Study contacts

• Principal investigator: Harry SOKOL, PU-PH — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Harry SOKOL, PU-PH

Conditions: Ulcerative Colitis, Ulcerative colitis, Inflammatory bowel disease, Fecal microbiota transplantation