Inclusion criteria | |
Individuals must satisfy the following criteria to be enrolled in the study: | |
1. Male or female aged ≥ 18 years at the time of signing the ICF. | |
2. Individual must understand and voluntarily sign an ICF before conducting the study-related assessments/procedure. | |
3. Willing and able to adhere to the scheduled study visits and other protocol requirements. | |
4. Individuals must have been operated with IPAA with a duration of at least 6 month before the screening visit. | |
5. Individuals must have a diagnosis of recurrent pouchitis defined as at least two episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation). | |
6. Individuals must be in remission with a PDAI < 7 at screening | |
7. Individuals must have affiliation with a social security system or be a beneficiary of such a system | |
8. Women of childbearing age must have a negative pregnancy test at screening and must agree to practice effective methods of contraception | |
Exclusion criteria | |
Individuals who meet any of the following exclusion criteria cannot be enrolled in this study: | |
1. Crohn’s disease or indeterminate colitis | |
2. Anastomotic stenosis | |
3. Individuals with prior treatment by probiotic within 3 months before the transplantation visit | |
4. Individuals with prior treatment by corticosteroids within 6 weeks before the transplantation visit | |
5. Individuals with prior treatment by immunosuppressors within 3 month before the transplantation visit | |
6. Prior treatment with a biologic within 3 month before the transplantation visit | |
7. Documented active infection of any kind in the last 6 months | |
8. ANC < 1.5 × 109 /L (1500 mm3) | |
9. Infection with chronic HIV | |
10. Pregnant or breastfeeding women | |
11. Chronic medical or psychiatric disease that may interfere with the individual’s ability to comply with study procedures | |
12. Administration of investigational drugs within 3 months before planned FMT | |
13. Adults under guardianship, safeguard justice, or trusteeship | |
14. Individuals with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation) | |
15. Patients with contraindication to colonoscopy or anesthesia (if necessary) |