Faecal Microbiota Transplantation in Ulcerative Colitis

Phase 2

Completed

• Conditions: Inflammatory Bowel Disease; Ulcerative Colitis
• Interventions: Other: Placebo infusion; Biological: FMT infusions

• Registration Number: NCT01896635
• Lead Sponsor: The University of New South Wales

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

Study Timeline

• Study First Submitted: 2013-07-06
• Study First Submitted QC: 2013-07-06
• Study First Posted: 2013-07-11
• Study Start: 2013-11
• Primary Completion: 2015-11
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo infusion	Placebo infusions
FMT infusions	FMT infusions	FMT infusions constituted from stool provided by healthy, screened donors

Primary Outcome Measures

Name	Time	Method
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores	8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical remission as measured by Mayo subscores	8 weeks
Endoscopic healing as measured by UCEIS	8 weeks
Treatment failure rate as defined by Mayo subscores	8 weeks
Safety and tolerability as measured by adverse event data	8 weeks
Clinical response as measured by Mayo subscores	8 weeks
Quality of life as measured by IBDQ	8 weeks

Trial Locations

Locations (3)

Nambour General Hospital; 🇦🇺 Nambour, Queensland, Australia

Bankstown-Lidcombe Hospital; 🇦🇺 Sydney, New South Wales, Australia

St Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia