Status:
COMPLETED
Faecal Microbiota Transplantation in Ulcerative Colitis
Lead Sponsor:
The University of New South Wales
Conditions:
Ulcerative Colitis
Inflammatory Bowel Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with ...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Active gastrointestinal infection
- Other gastrointestinal disease / comorbidities
- Prior colonic surgery
- Recent antibiotic or probiotic use
- Prednisone \> 20mg
- Monoclonal antibody immunosuppressive therapy
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01896635
Start Date
November 1 2013
End Date
August 1 2016
Last Update
October 25 2016
Active Locations (3)
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1
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
2
Bankstown-Lidcombe Hospital
Sydney, New South Wales, Australia, 2200
3
Nambour General Hospital
Nambour, Queensland, Australia, 4560