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Fecal Transplant for Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03078803
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
University of Calgary
McMaster University
Information provided by (Responsible Party):
University of Alberta

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

Condition or disease Intervention/treatment Phase
Crohn Disease Biological: Fecal Microbiota Transplant (FMT) Biological: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Clinical and Endoscopic Remission [ Time Frame: Week 8 ]
    Harvey Bradshaw Index <5 and Simple endoscopic score <5


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: Week 8 ]
    Harvey Bradshaw Index reduction by 3 points

  2. Clinical remission [ Time Frame: Week 8 ]
    Harvey Bradshaw Index <5

  3. Endoscopic response [ Time Frame: Week 8 ]
    Simple endoscopic score reduction by 50%

  4. Endoscopic remission [ Time Frame: Week 8 ]
    Simple endoscopic score <5

  5. Quality of Life 1 [ Time Frame: Week 8 ]
    Mean changes in Short Inflammatory Bowel Disease Questionnaire

  6. Quality of Life 2 [ Time Frame: Week 8 ]
    Mean changes in Euro five dimensions questionnaire

  7. Quality of Life 3 [ Time Frame: Week 8 ]
    Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Dina Kao, MD 780 492 8307 dkao@ualberta.ca

Locations
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Canada, Alberta
Foothills Hospital Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Humberto Jijon, MD    403 210 7013    jijon2@ucalgary.ca   
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Dina Kao, MD    780 492 8307      
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada
Contact: Paul Moayyedi, MD    905 521 2100 ext 73601    wolfe@hhsc.ca   
Sponsors and Collaborators
University of Alberta
University of Calgary
McMaster University
Investigators
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Principal Investigator: Dina Kao, MD University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03078803     History of Changes
Other Study ID Numbers: 66218
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:
fecal transplant
inflammatory bowel disease

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases