Fecal Transplant for Crohn's Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fecal Microbiota Transplant (FMT)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring fecal transplant, inflammatory bowel disease
Eligibility Criteria
Inclusion Criteria:
- mild to moderate ileal, ileo-colonic or colonic Crohns disease
- active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein >8mg/L, elevated fecal calprotectin >250 ug/g
- If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
- Use of effective contraception
Exclusion Criteria:
- Antibiotic exposure within 30 days and probiotic exposure within 14 days
- topical inflammatory bowel disease therapy within 2 weeks
- active perianal disease
- requirement for concurrent antibiotic therapy
- SES-CD score <5
- severe CD HBI >25 or need for hospitalization
- abdominal abscess
- extensive colonic resection, subtotal or total colectomy
- ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
- evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
- requiring or expected to require surgical intervention
- history or evidence of adenomatous colonic polyps not removed
- history of evidence of colonic dysplasia
- active substance abuse or psychiatric problems that may interfere with study
- chronic Hep B, C, or HIV infection
- pregnancy or planning to become pregnant
- upper CD
- history of adhesions preventing colonoscopy to cecum
- planned bowel resection within 3 mon of enrollment
Sites / Locations
- Foothills Hospital
- University of Alberta
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fecal microbiota transplant
Placebo
Arm Description
Transfer of healthy human gut bacteria
Water
Outcomes
Primary Outcome Measures
Clinical and Endoscopic Remission
Harvey Bradshaw Index <5 and Simple endoscopic score <5
Secondary Outcome Measures
Clinical response
Harvey Bradshaw Index reduction by 3 points
Clinical remission
Harvey Bradshaw Index <5
Endoscopic response
Simple endoscopic score reduction by 50%
Endoscopic remission
Simple endoscopic score <5
Quality of Life 1
Mean changes in Short Inflammatory Bowel Disease Questionnaire
Quality of Life 2
Mean changes in Euro five dimensions questionnaire
Quality of Life 3
Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire
Full Information
NCT ID
NCT03078803
First Posted
January 12, 2017
Last Updated
September 2, 2022
Sponsor
University of Alberta
Collaborators
University of Calgary, McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT03078803
Brief Title
Fecal Transplant for Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
August 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
University of Calgary, McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
fecal transplant, inflammatory bowel disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal microbiota transplant
Arm Type
Experimental
Arm Description
Transfer of healthy human gut bacteria
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant (FMT)
Other Intervention Name(s)
FMT
Intervention Description
FMT delivered by colonoscopy and oral capsules
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Transfer of water only
Primary Outcome Measure Information:
Title
Clinical and Endoscopic Remission
Description
Harvey Bradshaw Index <5 and Simple endoscopic score <5
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Clinical response
Description
Harvey Bradshaw Index reduction by 3 points
Time Frame
Week 8
Title
Clinical remission
Description
Harvey Bradshaw Index <5
Time Frame
Week 8
Title
Endoscopic response
Description
Simple endoscopic score reduction by 50%
Time Frame
Week 8
Title
Endoscopic remission
Description
Simple endoscopic score <5
Time Frame
Week 8
Title
Quality of Life 1
Description
Mean changes in Short Inflammatory Bowel Disease Questionnaire
Time Frame
Week 8
Title
Quality of Life 2
Description
Mean changes in Euro five dimensions questionnaire
Time Frame
Week 8
Title
Quality of Life 3
Description
Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild to moderate ileal, ileo-colonic or colonic Crohns disease
active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein >8mg/L, elevated fecal calprotectin >250 ug/g
If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
Use of effective contraception
Exclusion Criteria:
Antibiotic exposure within 30 days and probiotic exposure within 14 days
topical inflammatory bowel disease therapy within 2 weeks
active perianal disease
requirement for concurrent antibiotic therapy
SES-CD score <5
severe CD HBI >25 or need for hospitalization
abdominal abscess
extensive colonic resection, subtotal or total colectomy
ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
requiring or expected to require surgical intervention
history or evidence of adenomatous colonic polyps not removed
history of evidence of colonic dysplasia
active substance abuse or psychiatric problems that may interfere with study
chronic Hep B, C, or HIV infection
pregnancy or planning to become pregnant
upper CD
history of adhesions preventing colonoscopy to cecum
planned bowel resection within 3 mon of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Kao, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fecal Transplant for Crohn's Disease
We'll reach out to this number within 24 hrs