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Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)

This study has been completed.
Information provided by (Responsible Party):
Dr. Sudarshan Paramsothy, The University of New South Wales Identifier:
First received: July 6, 2013
Last updated: October 24, 2016
Last verified: October 2016
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

Condition Intervention Phase
Ulcerative Colitis
Inflammatory Bowel Disease
Biological: FMT infusions
Other: Placebo infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety

Resource links provided by NLM:

Further study details as provided by Dr. Sudarshan Paramsothy, The University of New South Wales:

Primary Outcome Measures:
  • Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores [ Time Frame: 8 weeks ]

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

Enrollment: 81
Study Start Date: November 2013
Study Completion Date: August 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01896635

Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Bankstown-Lidcombe Hospital
Sydney, New South Wales, Australia, 2200
Australia, Queensland
Nambour General Hospital
Nambour, Queensland, Australia, 4560
Sponsors and Collaborators
The University of New South Wales
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Sudarshan Paramsothy, Gastroenterologist / PhD candidate, The University of New South Wales Identifier: NCT01896635     History of Changes
Other Study ID Numbers: FOCUS
Study First Received: July 6, 2013
Last Updated: October 24, 2016

Keywords provided by Dr. Sudarshan Paramsothy, The University of New South Wales:
Ulcerative Colitis
Inflammatory Bowel Disease
Fecal Transplantation
Fecal Microbiota Transplantation

Additional relevant MeSH terms:
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes processed this record on May 25, 2017