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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis Inflammatory Bowel Disease | Biological: FMT infusions Other: Placebo infusion | Phase 2 |
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 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: FMT infusions
FMT infusions constituted from stool provided by healthy, screened donors
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Biological: FMT infusions
Active FMT derived from healthy anonymous pre-screened donors |
Placebo Comparator: Placebo arm
Placebo infusions
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Other: Placebo infusion
Placebo infusion not containing any donor microbial material |
- Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores [ Time Frame: 8 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
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

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 |
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 |
Responsible Party: | Dr. Sudarshan Paramsothy, Gastroenterologist / PhD candidate, The University of New South Wales |
ClinicalTrials.gov Identifier: | NCT01896635 |
Other Study ID Numbers: |
FOCUS |
First Posted: | July 11, 2013 Key Record Dates |
Last Update Posted: | October 25, 2016 |
Last Verified: | October 2016 |
Ulcerative Colitis Inflammatory Bowel Disease Fecal Transplantation Fecal Microbiota Transplantation |
Colitis Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |