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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01896635
Registration number
NCT01896635
Ethics application status
Date submitted
6/07/2013
Date registered
11/07/2013
Date last updated
25/10/2016
Titles & IDs
Public title
Faecal Microbiota Transplantation in Ulcerative Colitis
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Scientific title
Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
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Secondary ID [1]
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FOCUS
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Universal Trial Number (UTN)
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Trial acronym
FOCUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Inflammatory Bowel Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - FMT infusions
Other interventions - Placebo infusion
Active Comparator: FMT infusions - FMT infusions constituted from stool provided by healthy, screened donors
Placebo Comparator: Placebo arm - Placebo infusions
Other interventions: FMT infusions
Active FMT derived from healthy anonymous pre-screened donors
Other interventions: Placebo infusion
Placebo infusion not containing any donor microbial material
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
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Assessment method [1]
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Timepoint [1]
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8 weeks
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Secondary outcome [1]
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Clinical remission as measured by Mayo subscores
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Assessment method [1]
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Timepoint [1]
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8 weeks
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Secondary outcome [2]
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Clinical response as measured by Mayo subscores
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Assessment method [2]
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Timepoint [2]
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8 weeks
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Secondary outcome [3]
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Endoscopic healing as measured by UCEIS
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Assessment method [3]
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Timepoint [3]
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8 weeks
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Secondary outcome [4]
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Treatment failure rate as defined by Mayo subscores
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Assessment method [4]
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Timepoint [4]
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8 weeks
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Secondary outcome [5]
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Quality of life as measured by IBDQ
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Assessment method [5]
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Timepoint [5]
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8 weeks
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Secondary outcome [6]
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Safety and tolerability as measured by adverse event data
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Assessment method [6]
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Timepoint [6]
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8 weeks
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnancy
- Active gastrointestinal infection
- Other gastrointestinal disease / comorbidities
- Prior colonic surgery
- Recent antibiotic or probiotic use
- Prednisone > 20mg
- Monoclonal antibody immunosuppressive therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2016
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Sample size
Target
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Accrual to date
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Final
81
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment hospital [2]
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Bankstown-Lidcombe Hospital - Sydney
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Recruitment hospital [3]
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Nambour General Hospital - Nambour
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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2200 - Sydney
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Recruitment postcode(s) [3]
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4560 - Nambour
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01896635
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Hazel Mitchell, BSc PhD
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Address
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University of New South Wales
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01896635
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