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Faecal Microbiota Transplantation in Ulcerative Colitis (FOCUS)

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Disease

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
FMT infusions
Placebo infusion
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Inflammatory Bowel Disease, Fecal Transplantation, Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Vincent's Hospital
  • Bankstown-Lidcombe Hospital
  • Nambour General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

FMT infusions

Placebo arm

Arm Description

FMT infusions constituted from stool provided by healthy, screened donors

Placebo infusions

Outcomes

Primary Outcome Measures

Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores

Secondary Outcome Measures

Clinical remission as measured by Mayo subscores
Clinical response as measured by Mayo subscores
Endoscopic healing as measured by UCEIS
Treatment failure rate as defined by Mayo subscores
Quality of life as measured by IBDQ
Safety and tolerability as measured by adverse event data

Full Information

First Posted
July 6, 2013
Last Updated
October 24, 2016
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT01896635
Brief Title
Faecal Microbiota Transplantation in Ulcerative Colitis
Acronym
FOCUS
Official Title
Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales

4. Oversight

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Inflammatory Bowel Disease
Keywords
Ulcerative Colitis, Inflammatory Bowel Disease, Fecal Transplantation, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT infusions
Arm Type
Active Comparator
Arm Description
FMT infusions constituted from stool provided by healthy, screened donors
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo infusions
Intervention Type
Biological
Intervention Name(s)
FMT infusions
Intervention Description
Active FMT derived from healthy anonymous pre-screened donors
Intervention Type
Other
Intervention Name(s)
Placebo infusion
Intervention Description
Placebo infusion not containing any donor microbial material
Primary Outcome Measure Information:
Title
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical remission as measured by Mayo subscores
Time Frame
8 weeks
Title
Clinical response as measured by Mayo subscores
Time Frame
8 weeks
Title
Endoscopic healing as measured by UCEIS
Time Frame
8 weeks
Title
Treatment failure rate as defined by Mayo subscores
Time Frame
8 weeks
Title
Quality of life as measured by IBDQ
Time Frame
8 weeks
Title
Safety and tolerability as measured by adverse event data
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazel Mitchell, BSc PhD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alissa Walsh, MBBS
Organizational Affiliation
St Vincent's Hospital, Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johan van den Bogaerde, MBChB PhD
Organizational Affiliation
Nambour General Hospital, Queensland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Samuel, MBBS MMed
Organizational Affiliation
Bankstown-Lidcombe Hospital, Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadeem O Kaakoush, BSc PhD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Kamm, MBBS MD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Bankstown-Lidcombe Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Nambour General Hospital
City
Nambour
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30529583
Citation
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.
Results Reference
derived
PubMed Identifier
28214091
Citation
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.
Results Reference
derived
PubMed Identifier
26478682
Citation
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.
Results Reference
derived
PubMed Identifier
26070003
Citation
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.
Results Reference
derived

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Faecal Microbiota Transplantation in Ulcerative Colitis

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