Impact of Fecal Microbiota Transplantation in Ulcerative Colitis (REBALANCE-UC)

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Inflammatory bowel disease, Fecal microbiota transplantation Read More

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.