Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)

October 24, 2016 updated by: Dr. Sudarshan Paramsothy, The University of New South Wales

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
      • Sydney, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
    • Queensland
      • Nambour, Queensland, Australia, 4560
        • Nambour General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FMT infusions
FMT infusions constituted from stool provided by healthy, screened donors
Biological: FMT infusions
Active FMT derived from healthy anonymous pre-screened donors
Placebo Comparator: Placebo arm
Placebo infusions
Other: Placebo infusion
Placebo infusion not containing any donor microbial material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Investigators

  • Principal Investigator: Hazel Mitchell, BSc PhD, University of New South Wales
  • Principal Investigator: Alissa Walsh, MBBS, St Vincent's Hospital, Sydney
  • Principal Investigator: Johan van den Bogaerde, MBChB PhD, Nambour General Hospital, Queensland
  • Principal Investigator: Douglas Samuel, MBBS MMed, Bankstown-Lidcombe Hospital, Sydney
  • Principal Investigator: Nadeem O Kaakoush, BSc PhD, University of New South Wales
  • Principal Investigator: Michael Kamm, MBBS MD, University of Melbourne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 6, 2013

First Submitted That Met QC Criteria

July 6, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOCUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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