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Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)
This study has been completed.
Sponsor:
The University of New South Wales
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: October 24, 2016
Last verified: October 2016
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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 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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01896635
Locations
| 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
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
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 |
| 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 Ulcer Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 23, 2017