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Completed

NCT Number: NCT01896635

Faecal Microbiota Transplantation in Ulcerative Colitis

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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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bankstown-Lidcombe Hospital, Sydney, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMT infusions

Biological

Active FMT derived from healthy anonymous pre-screened donors

placebo infusion

Other

Placebo infusion not containing any donor microbial material

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Official study title

Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety

Acronym: FOCUS

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 11, 2013
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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