Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-06 @ 2:08 AM
Study NCT ID:
NCT03078803
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2017-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Transplant for Crohn's Disease
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease
Status:
COMPLETED
Status Verified Date:
2022-09
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:
None
Brief Summary:
To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease
Detailed Description:
Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated.
Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.
Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.
Colonoscopies recorded and reviewed by a central reader.
Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.
Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.
Colonoscopies recorded and reviewed by a central reader.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: