Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.

Korábbi kezelés

• Administration of investigational drug within 3 months prior to planned FMT
• Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
• Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
• Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit
• Prior treatment with a biologic within 3 month prior the transplantation visit

Más betegség

• Crohn disease or indeterminate colitis
• Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures
• Documented active infection of any kind in the last 6 months likely to require anti- infective treatment during the next months
• Infection with chronic HIV

Laborértékek

• Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)

Egyéb

• Pregnant female or breastfeeding
• Adults under guardianship, Safeguard justice or trusteeship
• Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
• Patients with contraindication to colonoscopy or anesthesia (if necessary)
• Anastomotic stenosis

• Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure
• Willing and able to adhere to the study visit scheduled and other protocol requirements
• Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
• 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).
• Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
• Subject must affiliation with social security system or beneficiary from such system
• Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception