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

Launched by NANTES UNIVERSITY HOSPITAL · May 11, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with recurrent pouchitis, a complication that can occur after surgery for ulcerative colitis. Pouchitis causes inflammation of the pouch created during surgery, leading to symptoms like increased stool frequency, urgency, and abdominal discomfort. The researchers aim to see if fecal microbiota transplantation (FMT), which involves transferring healthy bacteria from a donor to help restore a balanced gut environment, can help delay the return of pouchitis symptoms compared to a placebo treatment.

To participate in the trial, individuals must be at least 18 years old, have undergone surgery for ileal pouch-anal anastomosis at least six months prior, and have experienced recurrent pouchitis. Participants should be in a stable state without active inflammation at the start of the study. Those who join can expect to receive either the FMT treatment or a placebo, along with regular follow-up visits to monitor their health. It's important to note that not everyone will qualify for the trial—certain health conditions or recent treatments may prevent participation. This study is currently recruiting participants, and it's an opportunity for those struggling with chronic pouchitis to potentially benefit from a new therapy.

Gender

ALL

Eligibility criteria

• • 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 unless treatment has been introduced for more than 8 weeks at a stable dose.
• • 6. Prior treatment with a biologic within 3 month prior the transplantation visit unless treatment has been introduced for more than 8 weeks at a stable dose.
• • 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)