ALLOGENEIC FAECAL MICROBIOTA, POOLED for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years and < 75 years\n- Ulcerative colitis (according to the Lennard-Jones criteria) diagnosed for at least 3 months and: - Currently active (PMC score > 1) and planned to be treated by systemic corticosteroids (minimum 40mg prednisone equivalent daily) or - Currently treated by systemic corticosteroid (minimum 40mg prednisone equivalent daily) within maximum 3 weeks or \"REBALANCE UC\" protocol, version 12-0 of 04/07/2024 8/63 This document is the property of DRCI / APHP. All reproduction is strictly prohibited. Version date: January 2017 - Steroid dependent patients (at least one unsuccessful attempt to discontinue steroid within the last 6 months before inclusion)\n- Female of child-bearing age with an active contraception and this during at least the period of treatment until the end of active follow-up period (week 24)\n- Patient with health insurance (AME except)\n- Informed Written consent"}

Exclusion criteria

• {"criterion_text":"- UC Complication requiring surgical treatment\n- Patient treated with high dose corticosteroid more than three weeks before inclusion (≥40mg prednisone equivalent daily) except in case of steroid-dependence\n- Contraindication to colonoscopy or anesthesia\n- Pregnancy or breastfeeding (see definitions in annex C of the protocol)\n- 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\n- Participation in any other interventional study\n- Patients under legal protection."}

Primary endpoints

• {"endpoint_text":"- Steroid-free clinical and endoscopic remission at week 12 is 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).","definition_or_measurement_approach":"Defined as a total Mayo score of 2 or lower and no subscore higher than 1; mucosal healing defined as an endoscopic subscore of 0 or 1 assessed by sigmoidoscopy at week 12."}

Secondary endpoints

• {"endpoint_text":"- Steroid-free clinical remission is defined as a Partial Mayo Clinic score of 0 or 1","definition_or_measurement_approach":"Partial Mayo Clinic score of 0 or 1"}
• {"endpoint_text":"- Steroid-free endoscopic response is defined as a Mayo endoscopy subscore of 1 or less, with a reduction of at least 1 point from baseline","definition_or_measurement_approach":"Mayo endoscopy subscore of 1 or less with reduction ≥1 point from baseline"}
• {"endpoint_text":"- Steroid-free clinical remission is defined as a Partial Mayo Clinic score of 0 or 1","definition_or_measurement_approach":"Partial Mayo Clinic score of 0 or 1 (assessed at specified timepoints, e.g., week 24)"}
• {"endpoint_text":"- Steroid-free endoscopic remission is defined as Endoscopic Mayo Clinic subscore of 0.","definition_or_measurement_approach":"Endoscopic Mayo Clinic subscore of 0"}
• {"endpoint_text":"- Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor’s microbiota.","definition_or_measurement_approach":"16S sequencing to assess composition and diversity at baseline, week 12 and week 24 versus baseline and donor microbiota"}
• {"endpoint_text":"- Proportion of adverse events in each group (Abdominal pain, Nausea, vomiting, fever, modified intestinal transit, an episode of infection)","definition_or_measurement_approach":"Proportion of listed adverse events recorded per treatment group"}
• {"endpoint_text":"- Inflammatory biological parameter: CRP, fecal calprotectin, platelet number","definition_or_measurement_approach":"Laboratory measurement of CRP, fecal calprotectin and platelet count at scheduled visits"}
• {"endpoint_text":"- Endoscopic lesions at coloscopy and sigmoidoscopy (week 12) by endoscopic Mayo score and UCEIS score","definition_or_measurement_approach":"Endoscopic assessment using Mayo endoscopic subscore and UCEIS at baseline colonoscopy and week 12 sigmoidoscopy"}

France

Earliest CTIS Part Ii Submission Date

24-10-2024

Latest Decision Or Authorization Date

06-12-2024

Processing Time Days

43

Number Of Sites

12

Number Of Participants

350

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"French Ministry of Health","duties_or_roles":"Source of monetary support","organisation_type":""}