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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Fecal Microbiota Transplantation
serial Fecal Microbiota Transplantation
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Biological: Fecal Microbiota Transplant
serial FMT |
- 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.

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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 |
Inclusion Criteria:
- Age > 18 and < 65 years
- Diagnosis of UC for > 3 months but < 5 years prior to screening as determined by the investigators
- Those with mild to moderate UC
- Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) for > 3 months
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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
- ability to provide informed consent
- evidence of active inflammation
Exclusion Criteria:
- Those whose disease is limited to the rectum (ie. proctitis)
- Those with colectomy or diverting ileostomy
- Those who are pregnancy or plan to be pregnant during the trial
- Those who are breastfeeding or plan to breast feed during the trial
- Those who are on or have previously failed a biological agent
- Those with an active infection requiring antibiotic therapy
- 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
- Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
- Those with allergy to ciprofloxacin and metronidazole
- Those with colonic mucosal dysplasia

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
Canada, Alberta | |
University of Alberta Hospital | |
Edmonton, Alberta, Canada |
Principal Investigator: | Dina Kao, MD | University of Alberta |
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:
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |