Faecal Microbiota Transplantation in Ulcerative Colitis

NCT01896635 | Completed Phase 2

• 1 other identifier: FOCUS
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

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

Conditions

Ulcerative Colitis; Inflammatory Bowel Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (6)

• Clinical remission as measured by Mayo subscores

  8 weeks

• Clinical response as measured by Mayo subscores

  8 weeks

• Endoscopic healing as measured by UCEIS

  8 weeks

• Treatment failure rate as defined by Mayo subscores

  8 weeks

• Quality of life as measured by IBDQ

  8 weeks

Study Arms (2)

FMT infusions

ACTIVE COMPARATOR

FMT infusions constituted from stool provided by healthy, screened donors

Biological: FMT infusions

Placebo arm

PLACEBO COMPARATOR

Placebo infusions

Other: Placebo infusion

Interventions

FMT infusions BIOLOGICAL

Active FMT derived from healthy anonymous pre-screened donors

FMT infusions

Placebo infusion OTHER

Placebo infusion not containing any donor microbial material

Placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy
• Active gastrointestinal infection
• Other gastrointestinal disease / comorbidities
• Prior colonic surgery
• Recent antibiotic or probiotic use
• Prednisone \> 20mg
• Monoclonal antibody immunosuppressive therapy

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (3)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Bankstown-Lidcombe Hospital

Sydney, New South Wales, 2200, Australia

Location

Nambour General Hospital

Nambour, Queensland, 4560, Australia

Location

Related Publications (4)

• 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.

  PMID: 30529583 DERIVED

• 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.

  PMID: 28214091 DERIVED

• 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.

  PMID: 26478682 DERIVED

• 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.

  PMID: 26070003 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist / PhD candidate

Study Record Dates

• First Submitted: July 6, 2013
• First Posted: July 11, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: August 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

AU (3)