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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    42
  • sponsor
    Nantes University Hospital
Updated on 23 January 2021

Summary

Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available.

Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.

Details
Condition Pouchitis
Treatment Placebo, Fecal microbiota
Clinical Study IdentifierNCT03524352
SponsorNantes University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

Crohn disease or indeterminate colitis
Anastomotic stenosis
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
Documented active infection of any kind in the last 6 months
Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)
Infection with chronic HIV
Pregnant female or breastfeeding
Chronic medical or psychiatric disease that may interfere with subject's ability to comply with study procedures
Administration of investigational drug within 3 months prior to planned FMT
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)
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