Allogeneic faecal microbiota for Recurrent pouchitis | Ulcerative colitis with ileal-pouch-anal anastomosis (IPAA)

Inclusion criteria

• {"criterion_text":"- Male or female ≥ 18 years at the time of signing the informed consent form (ICF).\n- Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure\n- Willing and able to adhere to the study visit scheduled and other protocol requirements\n- Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.\n- Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation).\n- Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening\n- Subject must affiliation with social security system or beneficiary from such system\n- Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception"}

Exclusion criteria

• {"criterion_text":"- Crohn disease or indeterminate colitis\n- Pregnant female or breastfeeding\n- Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures\n- Administration of investigational drug within 3 months prior to planned FMT\n- Adults under guardianship, Safeguard justice or trusteeship\n- Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).\n- Patients with contraindication to colonoscopy or anesthesia (if necessary)\n- Anastomotic stenosis\n- Subject with prior treatment by probiotic within 3 month prior to the transplantation visit\n- Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit\n- Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit\n- Prior treatment with a biologic within 3 month prior the transplantation visit\n- Documented active infection of any kind in the last 6 months likely to require anti- infective treatment during the next months\n- Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)\n- Infection with chronic HIV"}

Primary endpoints

• {"endpoint_text":"- Delay between the date of transplantation and the date of the Clinical and endoscopic relapse defined by a Pouchitis Disease Activity Index (Appendix) ≥ 7 points.","definition_or_measurement_approach":"Time-to-event: relapse defined by Pouchitis Disease Activity Index (PDAI) ≥ 7 (clinical and endoscopic relapse)."}

Secondary endpoints

• {"endpoint_text":"- Relapse at week 24 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 24","definition_or_measurement_approach":"Relapse at Week 24 defined as PDAI ≥ 7 measured at week 24."}
• {"endpoint_text":"- Relapse at week 52 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 52","definition_or_measurement_approach":"Relapse at Week 52 defined as PDAI ≥ 7 measured at week 52."}
• {"endpoint_text":"- Delay within the transplantation and the instauration of an antibiotherapy or alternative treatment (immunosuppressive and/or biotherapy and/or corticotherapy)","definition_or_measurement_approach":"Time from transplantation to start of alternative treatment (antibiotics, immunosuppressive, biotherapy or corticosteroids)."}
• {"endpoint_text":"- Registered of adverse events defined by Common Terminology Criteria for Adverse Events (4.3) during 104 weeks post-transplantation according to ANSM recommendation.","definition_or_measurement_approach":"Safety: adverse events recorded per CTCAE v4.3 during 104 weeks after transplantation, per ANSM recommendations."}
• {"endpoint_text":"- Fecal microbiota engraftment at 8 weeks defined by : Sorensen’s index [receiver 8 weeks after FMT vs donor] > Sorensen’s index [receiver 8 weeks after FMT vs receiver before FMT]) with Sorensen’s index [receiver 8 weeks after FMT vs donor] = 0.6. To assess this endpoint, fecal microbiota composition will be analyzed for donor sample, receiver sample before FMT and 8 weeks after FMT, using 16S sequencing (Illumina Miseq technology)","definition_or_measurement_approach":"Microbiota engraftment assessed by 16S sequencing; success defined by Sorensen’s index comparisons with threshold criteria (receiver 8w vs donor > receiver 8w vs receiver before FMT and receiver 8w vs donor = 0.6)."}
• {"endpoint_text":"- IBD Disability Index at weeks -2, baseline, 8, 24, 52 and unscheduled visit","definition_or_measurement_approach":"Patient-reported IBD Disability Index measured at specified visits (Weeks -2, baseline, 8, 24, 52 and unscheduled visits)."}

France

Earliest CTIS Part Ii Submission Date

26-08-2024

Latest Decision Or Authorization Date

03-09-2024

Processing Time Days

8

Number Of Sites

14

Number Of Participants

42

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France