the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis (POCA)

This is an interventional treatment trial for Pouchitis focused on measuring recurrent pouchitis, fecal microbiota transplant Read More

4.2. INCLUSION CRITERIA

Subjects must satisfy the following criteria to be enrolled in the study:

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 (the antifungal medication is allowed until the day before transplantation).
6. Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
7. Subject must affiliation with social security system or beneficiary from such system
8. Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception

4.3. NON-INCLUSION CRITERIA

Subjects who meet any of the following non inclusion criteria could not be enrolled in this study:

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 likely to require anti-infective treatment during the next 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).
15. Patients with contraindication to colonoscopy or anesthesia (if necessary)