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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 February 2021 |
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Main ID: |
NCT02606032 |
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Date of registration:
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13/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
FMT |
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Scientific title:
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Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02606032 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Paul Moayyedi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hamilton HSC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients aged 18 or over
2. Active UC defined as a Mayo score > 3
3. A Mayo endoscopic score > 0
Exclusion Criteria:
1. Participating in another clinical trial
2. Unable to give informed consent
3. Severe co-morbid medical illness
4. Concomitant Clostridium difficile infection
5. Severe UC requiring hospitalization.
6. Increase in medical therapy for UC in the last 12 weeks. Continued treatment with
5-ASA, azathioprine, 6-mercaptopurine or anti-TNF alpha therapy (e.g. infliximab) will
be permitted if taken at stable dose for =12 weeks prior to randomization. Relapse on
a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will
also be permitted provided the dose of steroid is not increased again. Stable intake
of probiotic therapy also permitted.
7. Antibiotic therapy in the last 30 days.
8. Pregnant women.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Doxycycline
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Drug: Terbinafine
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Drug: Placebo
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Drug: Metronidazole
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Primary Outcome(s)
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The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis
[Time Frame: 9 weeks]
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Secondary ID(s)
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REB# 0163
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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