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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
Sponsor:
Information provided by (Responsible Party):
Dr. Sudarshan Paramsothy, The University of New South Wales

Tracking Information
First Submitted Date  ICMJE July 6, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2013)
Clinical remission as measured by Mayo subscores [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2013)
  • Clinical and Endoscopic remission as measured by Mayo subscores and UCEIS [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Faecal Microbiota Transplantation in Ulcerative Colitis
Official Title  ICMJE Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Inflammatory Bowel Disease
Intervention  ICMJE
  • Biological: FMT infusions
    Active FMT derived from healthy anonymous pre-screened donors
  • Other: Placebo infusion
    Placebo infusion not containing any donor microbial material
Study Arms  ICMJE
  • Active Comparator: FMT infusions
    FMT infusions constituted from stool provided by healthy, screened donors
    Intervention: Biological: FMT infusions
  • Placebo Comparator: Placebo arm
    Placebo infusions
    Intervention: Other: Placebo infusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
81
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2013)
80
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896635
Other Study ID Numbers  ICMJE FOCUS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sudarshan Paramsothy, The University of New South Wales
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account The University of New South Wales
Verification Date October 2016

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