Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis (FMT)
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|ClinicalTrials.gov Identifier: NCT02606032|
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : February 10, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Metronidazole Drug: Doxycycline Drug: Terbinafine Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||January 2021|
|Actual Study Completion Date :||January 27, 2021|
Active Comparator: Metronidazole+doxycylcine+terbinafine
Metronidazole 500 mg BID, Doxycycline 100 mg BID, Terbinafine 250 mg once daily all for 14 days
Other Name: Flagyl
Other Name: Vibramycin
Other Name: Lamisil
Placebo Comparator: Placebo
Placebo Metronidazole, Placebo Doxycycline, and Placebo Terbinafine all BID for 14 days
identical placebos to all antibiotics
- 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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients aged 18 or over
- Active UC defined as a Mayo score > 3
- A Mayo endoscopic score > 0
- 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.
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): NCT02606032
|Hamilton Health Sciences / McMaster University|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Paul Moayyedi, MD||Hamilton HSC|
|Responsible Party:||Paul Moayyedi, Director Division of Gastroenterology, Hamilton Health Sciences Corporation|
|Other Study ID Numbers:||
|First Posted:||November 17, 2015 Key Record Dates|
|Last Update Posted:||February 10, 2021|
|Last Verified:||February 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Fecal Microbiota Transplant
Digestive System Diseases
Inflammatory Bowel Diseases
Molecular Mechanisms of Pharmacological Action