Faecal Microbiota Transplantation in Ulcerative Colitis
NCT ID: NCT01896635
Last Updated: 2016-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2013-11-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FMT infusions
FMT infusions constituted from stool provided by healthy, screened donors
FMT infusions
Active FMT derived from healthy anonymous pre-screened donors
Placebo arm
Placebo infusions
Placebo infusion
Placebo infusion not containing any donor microbial material
Interventions
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FMT infusions
Active FMT derived from healthy anonymous pre-screened donors
Placebo infusion
Placebo infusion not containing any donor microbial material
Eligibility Criteria
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Inclusion Criteria
* 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
* Active gastrointestinal infection
* Other gastrointestinal disease / comorbidities
* Prior colonic surgery
* Recent antibiotic or probiotic use
* Prednisone \> 20mg
* Monoclonal antibody immunosuppressive therapy
18 Years
75 Years
ALL
No
Sponsors
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The University of New South Wales
OTHER
Responsible Party
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Dr. Sudarshan Paramsothy
Gastroenterologist / PhD candidate
Principal Investigators
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Hazel Mitchell, BSc PhD
Role: PRINCIPAL_INVESTIGATOR
University of New South Wales
Alissa Walsh, MBBS
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital, Sydney
Johan van den Bogaerde, MBChB PhD
Role: PRINCIPAL_INVESTIGATOR
Nambour General Hospital, Queensland
Douglas Samuel, MBBS MMed
Role: PRINCIPAL_INVESTIGATOR
Bankstown-Lidcombe Hospital, Sydney
Nadeem O Kaakoush, BSc PhD
Role: PRINCIPAL_INVESTIGATOR
University of New South Wales
Michael Kamm, MBBS MD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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St Vincent's Hospital
Sydney, New South Wales, Australia
Bankstown-Lidcombe Hospital
Sydney, New South Wales, Australia
Nambour General Hospital
Nambour, Queensland, Australia
Countries
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References
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Paramsothy S, Nielsen S, Kamm MA, Deshpande NP, Faith JJ, Clemente JC, Paramsothy R, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Lin E, Borody TJ, Wilkins MR, Colombel JF, Mitchell HM, Kaakoush NO. Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis. Gastroenterology. 2019 Apr;156(5):1440-1454.e2. doi: 10.1053/j.gastro.2018.12.001. Epub 2018 Dec 6.
Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.
Paramsothy S, Walsh AJ, Borody T, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush NO, Kamm MA. Gastroenterologist perceptions of faecal microbiota transplantation. World J Gastroenterol. 2015 Oct 14;21(38):10907-14. doi: 10.3748/wjg.v21.i38.10907.
Paramsothy S, Borody TJ, Lin E, Finlayson S, Walsh AJ, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush N, Kamm MA. Donor Recruitment for Fecal Microbiota Transplantation. Inflamm Bowel Dis. 2015 Jul;21(7):1600-6. doi: 10.1097/MIB.0000000000000405.
Other Identifiers
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FOCUS
Identifier Type: -
Identifier Source: org_study_id
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