Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis; Inflammatory Bowel Disease	Biological: FMT infusions; Other: Placebo infusion	Phase 2

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

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Clinical remission as measured by Mayo subscores [ Time Frame: 8 weeks ]
2. Clinical response as measured by Mayo subscores [ Time Frame: 8 weeks ]
3. Endoscopic healing as measured by UCEIS [ Time Frame: 8 weeks ]
4. Treatment failure rate as defined by Mayo subscores [ Time Frame: 8 weeks ]
5. Quality of life as measured by IBDQ [ Time Frame: 8 weeks ]
6. Safety and tolerability as measured by adverse event data [ Time Frame: 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

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

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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
First Posted:	July 11, 2013
Last Update Posted:	October 25, 2016
Last Verified:	October 2016

Keywords provided by Dr. Sudarshan Paramsothy, The University of New South Wales:

Ulcerative Colitis; Inflammatory Bowel Disease; Fecal Transplantation; Fecal Microbiota Transplantation

Additional relevant MeSH terms:

Colitis; Ulcer; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases	Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Pathologic Processes