Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized MedDRA version: 20.1 Level: LLT Classification code 10000638 Term: Active ileal inflammation System Organ Class: 100000004856
Conditions
Interventions
Product Name: suspension de microbiote fécal
Product Code: PRD5973697
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of
Sponsors
CHU Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years at the time of signing the informed consent form (ICF). 2. Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure. 3. Willing and able to adhere to the study visit scheduled and other protocol requirements. 4. Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit. 5. 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. 6. Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Crohn disease or indeterminate colitis 2. Anastomotic stenosis 3. Subject with prior treatment by probiotic within 3 month prior to the transplantation visit 4. Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit 5. Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit 6. Prior treatment with a biologic within 3 month prior the transplantation visit 7. Documented active infection of any kind in the last 6 months 8. Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3) 9. Infection with chronic HIV 10. Pregnant female or breastfeeding 11. Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures 12. Administration of investigational drug within 3 months prior to planned FMT 13. Adults under guardianship, Safeguard justice or trusteeship 14. Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the relapse delay after fecal microbiota transplantation versus sham transplantation for recurrent pouchitis in IPAA for ulcerative colitis.;Secondary Objective: Efficacy of fecal microbiota transplantation on the relapse rate at week 24 Efficacy of fecal microbiota transplantation on the relapse rate at week 52 Instauration of alternative treatment within week 52 Safety of a fecal microbiota transplantation in case of pouchitis Modifications of the fecal microbiota of a patient with ileal pouch for ulcerative colitis complicated of recurrent pouchitis, in remission after antibiotherapy after fecal transplant microbiota from a healthy donor at week 8 Evolution of health-related to disability ;Primary end point(s): 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. The Pouchitis Disease Activity Index (PDAI) is a 19 point index of pouchitis activity based on both clinical symptoms and endoscopic and histologic findings . Active pouchitis is defined as a PDAI = 7 and remission is defined as a PDAI < 7. Clinical response to treatment can also be quantified by reduction in the PDAI . ;Timepoint(s) of evaluation of this end point: 106 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Relapse at week 24 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 24 2- Relapse at week 52 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 52 3- Delay within the transplantation and the instauration of an antibiotherapy or alternative treatment (immunosuppressive and/or biotherapy and/or corticotherapy) 4- Registered of adverse events defined by Common Terminology Criteria for Adverse Events (4.3) during 104 weeks post-transplantation according to ANSM recommendation. 5- 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) 6- IBD Disability Index at weeks -5, baseline, 8, 24, 52 and unscheduled visit;Timepoint(s) of evaluation of this end point: 1_24 weeks 2_ 52 weeks 3_ 106 weeks 4_ 104 weeks post-transplantation 5_ 8 weeks 6_ weeks -5, baseline, 8 weeks, 24 weeks, 52weeks and 104 weeks | — |
Countries
France
Contacts
Public ContactDirection de la recherche
CHU de Nantes
Outcome results
None listed