Fecal Transplant for Crohn's Disease
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ClinicalTrials.gov Identifier: NCT03078803 |
Recruitment Status :
Completed
First Posted : March 13, 2017
Last Update Posted : September 7, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn Disease | Biological: Fecal Microbiota Transplant (FMT) Biological: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 28, 2017 |
Actual Primary Completion Date : | June 21, 2021 |
Actual Study Completion Date : | August 29, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Fecal microbiota transplant
Transfer of healthy human gut bacteria
|
Biological: Fecal Microbiota Transplant (FMT)
FMT delivered by colonoscopy and oral capsules
Other Name: FMT |
Placebo Comparator: Placebo
Water
|
Biological: Placebo
Transfer of water only |
- Clinical and Endoscopic Remission [ Time Frame: Week 8 ]Harvey Bradshaw Index <5 and Simple endoscopic score <5
- Clinical response [ Time Frame: Week 8 ]Harvey Bradshaw Index reduction by 3 points
- Clinical remission [ Time Frame: Week 8 ]Harvey Bradshaw Index <5
- Endoscopic response [ Time Frame: Week 8 ]Simple endoscopic score reduction by 50%
- Endoscopic remission [ Time Frame: Week 8 ]Simple endoscopic score <5
- Quality of Life 1 [ Time Frame: Week 8 ]Mean changes in Short Inflammatory Bowel Disease Questionnaire
- Quality of Life 2 [ Time Frame: Week 8 ]Mean changes in Euro five dimensions questionnaire
- Quality of Life 3 [ Time Frame: Week 8 ]Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078803
Canada, Alberta | |
Foothills Hospital | |
Calgary, Alberta, Canada, T2N2T9 | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2X8 | |
Canada, Ontario | |
McMaster University | |
Hamilton, Ontario, Canada |
Principal Investigator: | Dina Kao, MD | University of Alberta |
Responsible Party: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT03078803 |
Other Study ID Numbers: |
66218 |
First Posted: | March 13, 2017 Key Record Dates |
Last Update Posted: | September 7, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
fecal transplant inflammatory bowel disease |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |