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
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 patients randomised in a 1:1 manner to either active or placebo therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Active FMT derived from healthy anonymous pre-screened donors
Placebo infusion not containing any donor microbial material
St Vincent's Hospital
Sydney, New South Wales, Australia
Bankstown-Lidcombe Hospital
Sydney, New South Wales, Australia
Nambour General Hospital
Nambour, Queensland, Australia
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
Time frame: 8 weeks
Clinical remission as measured by Mayo subscores
Time frame: 8 weeks
Clinical response as measured by Mayo subscores
Time frame: 8 weeks
Endoscopic healing as measured by UCEIS
Time frame: 8 weeks
Treatment failure rate as defined by Mayo subscores
Time frame: 8 weeks
Quality of life as measured by IBDQ
Time frame: 8 weeks
Safety and tolerability as measured by adverse event data
Time frame: 8 weeks
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