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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 : Recruiting
First Posted : November 17, 2015
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Hamilton Academic Health Sciences Organization
Information provided by (Responsible Party):
Paul Moayyedi, Hamilton Health Sciences Corporation

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 the donor whose stool showed most efficacy in the trial (donor B). 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. The investigators will also use stool from donor B exclusively for frozen/thawed FMT as this donor was associated with the most success in the previous trial and this will be administered at St Joseph's Hospital under the care of Dr Lee. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 30, 2020


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




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 ]


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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.

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


Contacts
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Contact: Paul Moayyedi, MD 905-521-2100 ext 76764 moayyep@mcmaster.ca
Contact: Melanie Wolfe, CCRP 905-521-2100 ext 73601 wolfe@hhsc.ca

Locations
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Canada, Ontario
Hamilton Health Sciences / McMaster University Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Paul Moayyedi, MD    905-521-2100 ext 76764    moayyep@mcmaster.ca   
Contact: Melanie Wolfe, CCRP    905-521-2100 ext 73601    wolfe@hhsc.ca   
Principal Investigator: Paul Moayyedi, MD         
Sub-Investigator: John Marshall, MD         
Sub-Investigator: Walter Reinisch, MD         
St. Joseph's Hamilton Healthcare Active, not recruiting
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Hamilton Academic Health Sciences Organization
Investigators
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Principal Investigator: Paul Moayyedi, MD Hamilton HSC

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Responsible Party: Paul Moayyedi, Director Division of Gastroenterology, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02606032     History of Changes
Other Study ID Numbers: REB# 0163
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
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
Ulcer
Colitis, Ulcerative
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