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Register:	ClinicalTrials.gov
Last refreshed on:	7 November 2016
Main ID:	NCT01896635
Date of registration:	06/07/2013
Prospective Registration:	Yes
Primary sponsor:	The University of New South Wales
Public title:	Faecal Microbiota Transplantation in Ulcerative Colitis FOCUS
Scientific title:	Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Date of first enrolment:	November 2013
Target sample size:	81
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01896635
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
Phase:	Phase 2

Countries of recruitment
Australia

Contacts

Name:	Nadeem O Kaakoush, BSc PhD
Address:
Telephone:
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Affiliation:	University of New South Wales

Name:	Hazel Mitchell, BSc PhD
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Affiliation:	University of New South Wales

Name:	Douglas Samuel, MBBS MMed
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Affiliation:	Bankstown-Lidcombe Hospital, Sydney

Name:	Alissa Walsh, MBBS
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Affiliation:	St Vincent's Hospital, Sydney

Name:	Johan van den Bogaerde, MBChB PhD
Address:
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Affiliation:	Nambour General Hospital, Queensland

Name:	Michael Kamm, MBBS MD
Address:
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Affiliation:	University of Melbourne

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Ulcerative Colitis

Intervention(s)

Biological: FMT infusions

Other: Placebo infusion

Primary Outcome(s)

Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores [Time Frame: 8 weeks]

Secondary Outcome(s)

Endoscopic healing as measured by UCEIS [Time Frame: 8 weeks]

Safety and tolerability as measured by adverse event data [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]

Clinical response as measured by Mayo subscores [Time Frame: 8 weeks]

Clinical remission as measured by Mayo subscores [Time Frame: 8 weeks]

Secondary ID(s)

FOCUS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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