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Faecal Microbiota Transplantation in Ulcerative Colitis

NCT01896635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-10-25

No results posted yet for this study

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

Interventions

BIOLOGICAL

FMT infusions

Active FMT derived from healthy anonymous pre-screened donors

OTHER

Placebo infusion

Placebo infusion not containing any donor microbial material

Sponsors & Collaborators

  • The University of New South Wales

    lead OTHER

Principal Investigators

  • Hazel Mitchell, BSc PhD · University of New South Wales

  • Alissa Walsh, MBBS · St Vincent's Hospital, Sydney

  • Johan van den Bogaerde, MBChB PhD · Nambour General Hospital, Queensland

  • Douglas Samuel, MBBS MMed · Bankstown-Lidcombe Hospital, Sydney

  • Nadeem O Kaakoush, BSc PhD · University of New South Wales

  • Michael Kamm, MBBS MD · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-11-30
Completion
2016-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896635 on ClinicalTrials.gov