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Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02227342
Recruitment Status : Completed
First Posted : August 28, 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 IBD 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 UC 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
Ulcerative Colitis Biological: Fecal Microbiota Transplant Phase 1 Phase 2

Detailed Description:
same as above

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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 Ulcerative Colitis
Study Start Date : July 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
serial Fecal Microbiota Transplantation
 Biological: Fecal Microbiota Transplant
serial FMT


Outcome Measures
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Primary Outcome Measures :
  1. Mayo score reduction [ Time Frame: 12 and 32 weeks ]
    Patients with at least 3 point reduction in partial Mayo scoring index 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
  2. Diagnosis of UC for > 3 months but < 5 years prior to screening as determined by the investigators
  3. Those with mild to moderate UC
  4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) 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 or 6-MP must be at a stable dose for > 8 weeks

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

Exclusion Criteria:

  1. Those whose disease is limited to the rectum (ie. proctitis)
  2. Those with colectomy or diverting ileostomy
  3. Those who are pregnancy or plan to be pregnant during the trial
  4. Those who are breastfeeding or plan to breast feed during the trial
  5. Those who are on or have previously failed a biological agent
  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
  10. Those with colonic mucosal dysplasia
Contacts and Locations
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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): NCT02227342


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: NCT02227342     History of Changes
Other Study ID Numbers: 47056
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases