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:
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: December 2, 2014
Last verified: December 2014
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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 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
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 03, 2015