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CompletedNCT02227342Updated Dec 14, 2016

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

A Phase 1/2 interventional study of Fecal Microbiota Transplant in Ulcerative Colitis, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-12-14.

Sponsored by University of Alberta · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

same as above

02

Conditions studied

  • Ulcerative Colitis

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03

In context

Colitis, Ulcerative

1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.

This study's enrollment of 3 is below the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

University of Alberta is the lead sponsor of 819 studies on the registry; 168 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Fecal Microbiota Transplantation

    serial Fecal Microbiota Transplantation

    Biological: Fecal Microbiota Transplant

Interventions

06

What researchers measure

Primary outcomes

  1. Mayo score reduction

    Patients with at least 3 point reduction in partial Mayo scoring index at week 12 and at week 32 in the extension phase.

    Time frame: 12 and 32 weeks

07

Study locations

1 site
  • University of Alberta Hospital
    Edmonton, Alberta, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2014
First posted
Aug 28, 2014
Start
Jul 2014
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Dec 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02227342
Lead sponsor
University of Alberta
Responsible party
Dina Kao (Associate Professor, University of Alberta) — Principal investigator
First posted
Aug 28, 2014
Start date
Jul 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 14, 2016

Study contacts

Dina Kao, MD
principal investigator · University of Alberta

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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