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

Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03524352
Acronym
POCA
Enrollment
42
Registered
2018-05-14
Start date
2020-03-12
Completion date
2028-05-12
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pouchitis

Keywords

recurrent pouchitis, fecal microbiota transplant

Brief 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.

Interventions

fecal microbiota in suspension

OTHERPlacebo

sterile saline

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frame
Number of days between the date of transplantation and the date of relapse according to physiological and endoscopic parameter (pochitis disease activity index)106 weeks

Secondary

MeasureTime frame
Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index)24 weeks
Number of relapse rate according to pochitis disease activity index (physiological and endoscopic parameter)52 weeks
Number of days within the transplantation and the instauration of an antibiotherapy or alternative treatment52 weeks
Number of adverse events104 weeks
Number of fecal microbiota engraftment by 16S sequencing8 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)weeks -5

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026