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

NCT ID: NCT02227342

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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same as above

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fecal Microbiota Transplantation

serial Fecal Microbiota Transplantation

Group Type EXPERIMENTAL

Fecal Microbiota Transplant

Intervention Type BIOLOGICAL

serial FMT

Interventions

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Fecal Microbiota Transplant

serial FMT

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Dina Kao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Kao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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47056

Identifier Type: -

Identifier Source: org_study_id