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Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02199561
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dina Kao, University of Alberta

Study Description
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Brief Summary:
Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for CD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: Fecal Microbiota Transplant Phase 1 Phase 2

Detailed Description:
Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6. Assessments include HBI score, SES-CD score, and serum CRP levels.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Study Start Date : July 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fecal Microbiota Transplant
Open label single arm delivering fecal transplant to each participant
 Biological: Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donor


Outcome Measures
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Primary Outcome Measures :
  1. HBI score reduction [ Time Frame: 12 and 32 weeks ]
    Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 and < 65 years at the time of screening
  2. Diagnosis of ileo-colonic or colonic CD for > 3 months but < 5 years prior to screening as determined by the investigators
  3. Those with mild to moderate CD
  4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate for > 3 months

  5. Where applicable, those who are taking the following medications must be at a stable dose defined as:

    i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine, 6-MP, and methotrexate must be at a stable dose for > 8 weeks

  6. ability to provide informed consent
  7. evidence of active colonic inflammation

Exclusion Criteria:

  1. Those with prior ileo-cecal resection
  2. Those who are pregnancy or plan to be pregnant during the trial
  3. Those who are breastfeeding or plan to breast feed during the trial
  4. Those who are on or have previously failed a biological agent
  5. Those who have active perianal disease as determined by investigators
  6. Those with an active infection requiring antibiotic therapy
  7. Those with positive stool cultures for known pathogens such as E coli, Salmonella, Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of enrollment
  8. Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
  9. Those with allergy to ciprofloxacin and metronidazole
Contacts and Locations
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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): NCT02199561


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Dina Kao, MD University of Alberta
More Information
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Responsible Party: Dina Kao, Associate professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02199561    
Other Study ID Numbers: 47055
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases