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

Study acronym: POCA
StatusActive, Not Recruiting
PhasePhase 3
Started2020-03-12
View on ClinicalTrials.gov ↗

Amendment history

2026-02-12
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 13 of 13 sites
2025-04-15
Study Status, Oversight, Eligibility, Contacts/Locations v6
Study sites12→13
Eligibility criteria+154 characters
[...] uppressors within 3 month prior to the transplantation visit unless treatment has been introduced for more than 8 weeks at a stable dose. 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. Documented active infection of any kind in the last 6 month [...]
2023-06-14
Study Status v5
Primary completion date2026-05-01→2028-05-12
Completion date2026-05-01→2028-05-12
Start date2018-09-01→2020-03-12
2022-07-20
Study Status, Eligibility, Contacts/Locations v4
Primary completion date2024-09-01→2026-05-01
Completion date2024-09-01→2026-05-01
Eligibility criteria+327 characters
Inclusion4.2. CriteriaINCLUSION CRITERIA Subjects must satisfy the following criteria to be enrolled in the study: Male or female ≥ 18 years at the time of signing the infor [...] ng 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 Acti [...] d must agree to practice effective methods of contraception Exclusion4.3. CriteriaNON-INCLUSION CRITERIA Subjects who meet any of the following non inclusion criteria could not be enrolled in this study: Crohn disease or indetermin [...] [...]
Study sitesdetails revised at 10 of 12 sites
2019-10-23
Study Status, Contacts/Locations v3
Study sites1→12
Show 2 earlier versions
2018-07-13
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-10-01→2024-09-01
Completion date2024-10-01→2024-09-01
Start date2018-06-01→2018-09-01
Eligibility criteria+75 characters
[...] n, job transfer, geographical distance, lack of motivation). Patients with contraindication to colonoscopy or anesthesia (if necessary)
Study sitesdetails revised at 1 of 1 site
2018-05-17
Study Identification, Study Status, Outcome Measures v1
Secondary endpoints10 entries, revised
Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index) Number of relapse rate according to pochitis disease activity index (physiological and endoscopic parameter) DelayNumber of days within the transplantation and the instauration of an antib [...] alternative treatment Number of fecal microbiota engraftment by 16S sequencing Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index) Number of evolution of health-related to disability according to physiological and end [...] [...]
Primary endpoints1 entry, revised
DelayNumber of days between the date of transplantation and the date of therelapse Clinicalaccording to physiological and endoscopic relapseparameter (pochitis disease activity index)
Study title-74 characters
Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
2018-05-11
Original filing
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.
Trial Details
NCT Number NCT03524352
Lead Sponsor Nantes University Hospital
Conditions Pouchitis
Enrollment 42 participants
Start Date 2020-03-12
Primary Completion 2028-05-12 (estimated)
Study Completion 2028-05-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-17