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Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis (FMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 13, 2015
First Posted Date  ICMJE November 17, 2015
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
Official Title  ICMJE Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Metronidazole
    active comparator
    Other Name: Flagyl
  • Drug: Doxycycline
    active comparator
    Other Name: Vibramycin
  • Drug: Terbinafine
    active comparator
    Other Name: Lamisil
  • Drug: Placebo
    identical placebos to all antibiotics
Study Arms  ICMJE
  • Active Comparator: Metronidazole+doxycylcine+terbinafine
    Metronidazole 500 mg BID, Doxycycline 100 mg BID, Terbinafine 250 mg once daily all for 14 days
    Interventions:
    • Drug: Metronidazole
    • Drug: Doxycycline
    • Drug: Terbinafine
  • Placebo Comparator: Placebo
    Placebo Metronidazole, Placebo Doxycycline, and Placebo Terbinafine all BID for 14 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2021)
75
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
80
Actual Study Completion Date  ICMJE January 27, 2021
Actual Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02606032
Other Study ID Numbers  ICMJE REB# 0163
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Paul Moayyedi, Hamilton Health Sciences Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hamilton Academic Health Sciences Organization
Investigators  ICMJE
Principal Investigator: Paul Moayyedi, MD Hamilton HSC
PRS Account Hamilton Health Sciences Corporation
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP