This trial has been completed.

Conditions ulcerative colitis, inflammatory bowel disease
Treatments fmt infusions, placebo infusion
Phase phase 2
Sponsor The University of New South Wales
Start date November 2013
End date November 2015
Trial size 81 participants
Trial identifier NCT01896635, FOCUS


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
FMT infusions constituted from stool provided by healthy, screened donors
fmt infusions
Active FMT derived from healthy anonymous pre-screened donors
(Placebo Comparator)
Placebo infusions
placebo infusion
Placebo infusion not containing any donor microbial material

Primary Outcomes

Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
time frame: 8 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Principal investigator Hazel Mitchell, BSc PhD
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 patients randomised in a 1:1 manner to either active or placebo therapy
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by The University of New South Wales.