Impact of Fecal Microbiota Transplantation in Ulcerative Colitis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 23, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effects of fecal microbiota transplantation (FMT) on patients with ulcerative colitis (UC), a long-term condition that causes inflammation in the intestines. The goal is to see if this treatment can help improve symptoms in people who have active UC. The trial is open to adults aged 18 to 75 who have been diagnosed with UC for at least three months and are currently experiencing active symptoms. Additionally, participants should either be on a specific dose of corticosteroids or have a history of needing them.

Participants in the trial can expect to undergo a procedure where healthy stool from a donor is transplanted into their intestines to help restore a balanced gut microbiome. To be eligible, patients must have health insurance and provide informed consent. Those who are pregnant, have certain complications, or have received specific treatments recently are not eligible. The study is currently recruiting participants, and both patients and healthy volunteers who meet the criteria can take part. If you're considering joining, you’ll be contributing to important research that could lead to better treatment options for ulcerative colitis.

Gender

ALL

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.