Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02606032 |
Other study ID # |
REB# 0163 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
May 2016 |
Est. completion date |
January 27, 2021 |
Study information
Verified date |
February 2021 |
Source |
Hamilton Health Sciences Corporation |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.