Faecal Microbiota Transplantation in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— FOCUS  

Official title:

Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896635
• Other study ID #: FOCUS
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2013
• Last updated: October 24, 2016
• Start date: November 2013
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• FMT infusions
Active FMT derived from healthy anonymous pre-screened donors

Other:
• Placebo infusion
Placebo infusion not containing any donor microbial material

Locations

Country	Name	City	State
Australia	Nambour General Hospital	Nambour	Queensland
Australia	Bankstown-Lidcombe Hospital	Sydney	New South Wales
Australia	St Vincent's Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores		8 weeks	No
Secondary	Clinical remission as measured by Mayo subscores		8 weeks	No
Secondary	Clinical response as measured by Mayo subscores		8 weeks	No
Secondary	Endoscopic healing as measured by UCEIS		8 weeks	No
Secondary	Treatment failure rate as defined by Mayo subscores		8 weeks	No
Secondary	Quality of life as measured by IBDQ		8 weeks	No
Secondary	Safety and tolerability as measured by adverse event data		8 weeks	Yes