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Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)

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ClinicalTrials.gov Identifier: NCT01896635
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):

Study Description
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

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : November 2013
Primary Completion Date : November 2015
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Sudarshan Paramsothy, Gastroenterologist / PhD candidate, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01896635     History of Changes
Other Study ID Numbers: FOCUS
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 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