Ulcerative Colitis Clinical Trial
— FOCUSOfficial title:
Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial
Status | Completed |
Enrollment | 81 |
Est. completion date | August 2016 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Ulcerative colitis >3 months duration - Active mild-moderate ulcerative colitis (Mayo 4-10) - Ulcerative colitis of any extent except isolated proctitis < 5cm - Live within driving distance of clinical site (to attend multiple study visits) Exclusion Criteria: - Pregnancy - Active gastrointestinal infection - Other gastrointestinal disease / comorbidities - Prior colonic surgery - Recent antibiotic or probiotic use - Prednisone > 20mg - Monoclonal antibody immunosuppressive therapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Nambour General Hospital | Nambour | Queensland |
Australia | Bankstown-Lidcombe Hospital | Sydney | New South Wales |
Australia | St Vincent's Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
The University of New South Wales |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores | 8 weeks | No | |
Secondary | Clinical remission as measured by Mayo subscores | 8 weeks | No | |
Secondary | Clinical response as measured by Mayo subscores | 8 weeks | No | |
Secondary | Endoscopic healing as measured by UCEIS | 8 weeks | No | |
Secondary | Treatment failure rate as defined by Mayo subscores | 8 weeks | No | |
Secondary | Quality of life as measured by IBDQ | 8 weeks | No | |
Secondary | Safety and tolerability as measured by adverse event data | 8 weeks | Yes |
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