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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
Sponsor:
Collaborator:
Hamilton Academic Health Sciences Organization
Information provided by (Responsible Party):
Paul Moayyedi, Hamilton Health Sciences Corporation

Study Description
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Brief Summary:
The investigators will test the hypothesis that giving antibiotics prior to fecal transplant therapy for active UC increases the proportion of patients in remission at the end of treatment. The investigators will randomize patients aged 18 or over with active UC to antibiotics (metronidazole 500mg, doxycycline 100mg, Terbinafine 250 mg, all twice daily for two weeks); or identical placebo. At the end of two weeks the investigators will give all patients fecal transplant therapy twice per week for eight weeks from an anonymous donor stool.). Patients will complete a validated UC questionnaire, have a flexible sigmoidoscopy to assess the degree of inflammation in the colon and complete general and disease specific quality of life questionnaire as well as a questionnaire on anxiety and depression. Patients will complete the same questionnaires again at the end of treatment at week 9 when they will also have a repeat flexible sigmoidoscopy. The main outcome that will be assessed is the proportion of patients in remission from their UC at the end of treatment.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Metronidazole Drug: Doxycycline Drug: Terbinafine Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Drug: Metronidazole
active comparator
Other Name: Flagyl

Drug: Doxycycline
active comparator
Other Name: Vibramycin

Drug: Terbinafine
active comparator
Other Name: Lamisil
Placebo Comparator: Placebo
Placebo Metronidazole, Placebo Doxycycline, and Placebo Terbinafine all BID for 14 days
 Drug: Placebo
identical placebos to all antibiotics


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Hamilton Health Sciences / McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Hamilton Academic Health Sciences Organization
Investigators
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Principal Investigator: Paul Moayyedi, MD Hamilton HSC
More Information
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Responsible Party: Paul Moayyedi, Director Division of Gastroenterology, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02606032    
Other Study ID Numbers: REB# 0163
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
Keywords provided by Paul Moayyedi, Hamilton Health Sciences Corporation:
Fecal Microbiota Transplant
Antibiotics
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Metronidazole
 Doxycycline
Terbinafine
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action