Viewing Study NCT01896635


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Study NCT ID: NCT01896635
Status: COMPLETED
Last Update Posted: 2016-10-25
First Post: 2013-07-06
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Faecal Microbiota Transplantation in Ulcerative Colitis
Sponsor: The University of New South Wales
Organization:

Study Overview

Official Title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Status: COMPLETED
Status Verified Date: 2016-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FOCUS
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

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: