Status:
COMPLETED
Faecal Microbiota Transplantation From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis
Lead Sponsor:
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Conditions:
Pouchitis
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with chronic pouchitis is disabled by bloody diarrhoea and abdominal pain often followed by fever. Pouchitis is an inflammation in a pouch, a reservoir formed by the small intestine in the ma...
Detailed Description
Hypothesis: Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT with stool from a normal function pouch patient has a clinical effect by induci...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years of age with a J-pouch
- PDAI ≥ 7
- Established diagnosis of chronic pouchitis (≥3 times of pouchitis within the last year, symptoms more than 4 weeks despite antibiotic treatment)
- Antibiotic treatment for pouchitis (ciprofloxacin and/or metronidazole) within the 3 months
Exclusion
- Immunosuppression
- Pregnancy or breastfeeding
- Evidence of intestinal pathogen bacteria in the stool at inclusion visit
- Any severe or newly diagnosed concomitant cardiovascular, hepatic, intestinal, renal, endocrine, pulmonary, dental disease with inflammation or psychiatric disorder, which, in the opinion of the investigator, might have an influence on the patient's compliance or the interpretation of the results
- Probiotic intake within the last 2 weeks prior to study intervention
- Participation in another clinical trial within the previous 30 days before baseline
- Serious food allergies with earlier anaphylactic reactions
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04820413
Start Date
March 1 2021
End Date
March 15 2022
Last Update
July 13 2022
Active Locations (1)
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1
Department of Gastrointestinal Surgery, Aalborg University Hospital
Aalborg, Denmark, 9000