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Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by The University of New South Wales
Sponsor:
Information provided by (Responsible Party):
Dr. Sudarshan Paramsothy, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01896635
First received: July 6, 2013
Last updated: December 2, 2014
Last verified: December 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 The University of New South Wales:

Primary Outcome Measures:
  • Clinical remission as measured by Mayo subscores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and Endoscopic remission as measured by Mayo subscores and UCEIS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical response as measured by Mayo subscores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Endoscopic healing as measured by UCEIS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Treatment failure rate as defined by Mayo subscores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Quality of life as measured by IBDQ [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability as measured by adverse event data [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896635

Contacts
Contact: Sudarshan Paramsothy, MBBS (61 2) 8382 2061 sparam_au@yahoo.com

Locations
Australia, New South Wales
Bankstown-Lidcombe Hospital Recruiting
Sydney, New South Wales, Australia, 2200
Contact: Douglas Samuel, MBBS MMed         
Principal Investigator: Douglas Samuel, MBBS MMed         
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Alissa Walsh, MBBS         
Principal Investigator: Alissa Walsh, MBBS         
Australia, Queensland
Nambour General Hospital Recruiting
Nambour, Queensland, Australia, 4560
Contact: Johan van den Bogaerde, MBChB PhD         
Principal Investigator: Johan van den Bogaerde, MBChB PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

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
Study First Received: July 6, 2013
Last Updated: December 2, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by The University of New South Wales:
Ulcerative Colitis
Inflammatory Bowel Disease
Fecal Transplantation
Fecal Microbiota Transplantation

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on March 01, 2015