Status:
TERMINATED
Faecal Microbiota Transplantation 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 the chronic bowel disease 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 i...
Detailed Description
Hypothesis: Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT has a clinical effect by inducing clinical remission in patients with chronic p...
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 last year
- Not pregnant or breastfeeding
Exclusion
- Immunosuppression
- Pregnancy
- 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 :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04100291
Start Date
July 1 2019
End Date
March 1 2022
Last Update
July 14 2022
Active Locations (2)
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1
Department of Gastrointestinal Surgery, Aalborg University Hospital
Aalborg, Denmark, 9000
2
Department of Medical Gastroenterology, Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650