- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02606032
Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis (FMT)
Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients aged 18 or over with active UC defined as a Mayo score > 3 with an endoscopic score >0 will be eligible for the study. Subjects will be excluded if they are participating in another clinical trial, are unable to give informed consent, have severe comorbid medical illness, have concomitant Clostridium difficile infection or have severe UC requiring hospitalization. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNFα therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Eligible patients will be randomized 1:1 to metronidazole 500mg bid, doxycycline 100mg bid, Terbinafine 250 mg and or identical placebos all for two weeks. Patients will all then receive their first FMT 1-3 days after completing their course of antibiotic/placebo. FMT will be administered twice per week for 8 weeks.
Eighty active UC patients will be randomized 1:1 according to a computer generated randomization list. Randomization will be administered centrally at the GI Clinical Trials Unit to ensure concealment of allocation.
Subjects will have a sigmoidoscopy (or colonoscopy if clinically indicated), physician assessment and complete a Mayo score, IBDQ questionnaire, EQ5D and HAD questionnaires at baseline. A repeat sigmoidoscopy, Mayo score, IBDQ, EQ5D and HAD questionnaires will be completed at 9 weeks, at exit from the study (one week after last FMT). No new medical therapies (e.g. corticosteroids, antibiotics, probiotics) will be permitted during the 9 week study period.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Hamilton Health Sciences / McMaster University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 18 or over
- Active UC defined as a Mayo score > 3
- A Mayo endoscopic score > 0
Exclusion Criteria:
- Participating in another clinical trial
- Unable to give informed consent
- Severe co-morbid medical illness
- Concomitant Clostridium difficile infection
- Severe UC requiring hospitalization.
- 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.
- Antibiotic therapy in the last 30 days.
- Pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metronidazole+doxycylcine+terbinafine
Metronidazole 500 mg BID, Doxycycline 100 mg BID, Terbinafine 250 mg once daily all for 14 days
|
active comparator
Other Names:
active comparator
Other Names:
active comparator
Other Names:
|
Placebo Comparator: Placebo
Placebo Metronidazole, Placebo Doxycycline, and Placebo Terbinafine all BID for 14 days
|
identical placebos to all antibiotics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
9 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paul Moayyedi, MD, Hamilton HSC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Metronidazole
- Doxycycline
- Terbinafine
Other Study ID Numbers
- REB# 0163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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