Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, Inflammatory Bowel Disease, Fecal Transplantation, Fecal Microbiota Transplantation
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 controlled trial
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 patients randomised in a 1:1 manner to either active or placebo therapy
Interventions
BIOLOGICALFMT infusions
Active FMT derived from healthy anonymous pre-screened donors
OTHERPlacebo infusion
Placebo infusion not containing any donor microbial material
Sponsors
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response as measured by Mayo subscores | 8 weeks |
| Endoscopic healing as measured by UCEIS | 8 weeks |
| Clinical remission as measured by Mayo subscores | 8 weeks |
| Quality of life as measured by IBDQ | 8 weeks |
| Safety and tolerability as measured by adverse event data | 8 weeks |
| Treatment failure rate as defined by Mayo subscores | 8 weeks |
Countries
Australia
Outcome results
None listed