Ulcerative ColitisPhase 2FMTNCT02606032
Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
A Phase 2 study testing Metronidazole, Doxycycline and Terbinafine in people with Ulcerative Colitis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Metronidazole, Doxycycline and Terbinafine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 27 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or over
- Active UC defined as a Mayo score > 3
- A Mayo endoscopic score > 0
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences / McMaster University
Hamilton, Ontario, L8N 3Z5
About this study
Official title: Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Metronidazole, Doxycycline, Terbinafine, Placebo
- Keywords
- Fecal Microbiota Transplant, Antibiotics
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
active comparator
DoxycyclineDrug
Also called Vibramycin
active comparator
TerbinafineDrug
Also called Lamisil
active comparator
PlaceboDrug
identical placebos to all antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole+doxycylcine+terbinafine | Active comparator | Metronidazole 500 mg BID, Doxycycline 100 mg BID, Terbinafine 250 mg once daily all for 14 days Receives: Drug: Metronidazole; Drug: Doxycycline; Drug: Terbinafine |
| Placebo | Placebo comparator | Placebo Metronidazole, Placebo Doxycycline, and Placebo Terbinafine all BID for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMay 2016
- Primary completionJan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Principal investigator, Paul Moayyedi, Hamilton Health Sciences Corporation
- Investigators
- Paul Moayyedi, MD, Principal investigator, Hamilton HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606032
- Sponsor's protocol ID
- REB# 0163
- Acronym
- FMT
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2015
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02606032
- Acronym / sponsor ID
- FMT / REB# 0163
- Conditions
- Ulcerative Colitis
- Keywords
- Fecal Microbiota Transplant, Antibiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole+doxycylcine+terbinafine | Active comparator | Drug: Metronidazole, Drug: Doxycycline, Drug: TerbinafineMetronidazole 500 mg BID, Doxycycline 100 mg BID, Terbinafine 250 mg once daily all for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Metronidazole, Placebo Doxycycline, and Placebo Terbinafine all BID for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 or over
- Active UC defined as a Mayo score > 3
- A Mayo endoscopic score > 0
Key exclusion criteria (8 listed)
- Participating in another clinical trial
- Unable to give informed consent
- Severe co-morbid medical illness
- Concomitant Clostridium difficile infection
- Severe UC requiring hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleAlso: Flagylactive comparator | Drug | Metronidazole+doxycylcine+terbinafine |
| DoxycyclineAlso: Vibramycinactive comparator | Drug | Metronidazole+doxycylcine+terbinafine |
| TerbinafineAlso: Lamisilactive comparator | Drug | Metronidazole+doxycylcine+terbinafine |
| Placeboidentical placebos to all antibiotics | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Moayyedi, MD principal investigator
Hamilton HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metronidazole, Doxycycline and Terbinafine in people with Ulcerative Colitis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.