Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)

The University of New South Wales

Status and phase: Completed; Phase 2

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis

Treatments: Other: Placebo infusion; Biological: FMT infusions

Study type: Interventional

Funder types: Other

Identifiers

NCT01896635

FOCUS

Details and patient eligibility

About

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

Full 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

Enrollment: 81 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

FMT infusions

Active Comparator group

Description:

FMT infusions constituted from stool provided by healthy, screened donors

Treatment:

Biological: FMT infusions

Placebo arm

Placebo Comparator group

Description:

Placebo infusions

Treatment:

Other: Placebo infusion