- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03832400
Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC)
A Phase 1b, Placebo-controlled, Study of the Safety and Efficacy of MET-2 in Patients With Ulcerative Colitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild to Moderate UC.
- ≥ 18 years old.
- Able to provide informed consent, or have a caregiver able to provide consent.
Subjects must have a documented diagnosis (radiologic or endoscopic with histology) of UC for >3 months before screening. The following must be available in each subject's source documentation:
- A biopsy report to confirm the histological diagnosis
- A report documenting disease duration and medication history prior to study colonoscopy
Subjects receiving any treatment(s) forUC are eligible provided they are anticipated to be on a stable dose for the duration of the study period and have been on therapy prior to the randomization visit for the following amount of time:
Prednisone - 4 weeks; Budesonide - 4 weeks; 5-aminosalicylic acid (5-ASA) containing products - 4 weeks; Thiopurine analogs (azathioprine, 6-mercaptopurine) - 12 weeks; Biologic therapy (infliximab, adalimumab, vedolizumab) - 12 weeks; Tofacitinib - 8 weeks.
No change in dose is permitted for the following time period prior to the randomization visit:
Prednisone - 2 weeks; Budesonide - 4 weeks; 5-ASA containing products - 4 weeks; Thiopurine analogs (azathioprine, 6-mercaptopurine) - 6 weeks; Biologic therapy (infliximab, adalimumab, vedolizumab) - 6 weeks; Tofacitinib - 4 weeks.
- Subjects are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use acceptable contraception for the duration of the study.
- Willing to participate in follow up as part of the study.
Exclusion Criteria:
- Ulcerative colitis with disease limited to only the distal rectum (<5cm from dentate line).
- Subjects with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease will be excluded.
- Subjects with colonic dysplasia or neoplasia. (Subjects with prior history of adenomatous polyps will be eligible if the polyps have been completely removed).
- Subjects with toxic megacolon or hospitalized for ulcerative colitis.
- Subjects with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
- Use of antibiotics within 6 weeks of randomization visit.
- Allergy to vancomycin.
- Elective surgery that will require preoperative antibiotics planned within 3 months of enrolment.
- Pregnant or planning to get pregnant in the next 6 months.
- Any condition for which, in the opinion of the investigator, the subject should be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MET-2 20 g
Subjects will be given a once-daily loading dose of 5 grams (g) of MET-2 in the form of 10 MET-2 capsules orally for the first 4 days.
For the following 10 days, patients will take 1.5 g MET-2 in the form of three MET-2 capsules taken once-daily
|
MET-2 is a defined consortium of human commensal bacteria derived from a healthy donor, which has the full metabolic functional capacity of fecal microbiota.
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Experimental: MET-2 40 g
Subjects will be given a once-daily loading dose of 10 g of MET-2 in the form of 20 MET-2 capsules orally for the first 4 days.
For the following 10 days, subjects will take 1.5 g MET-2 in the form of three MET-2 capsules taken once daily
|
MET-2 is a defined consortium of human commensal bacteria derived from a healthy donor, which has the full metabolic functional capacity of fecal microbiota.
|
Placebo Comparator: Placebo oral capsule
Subjects receive 10 placebo capsules that are identical in appearance to the MET-2 capsules
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Placebo oral capsule which is identical to the MET-2 capsules.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut Microbiome restoration
Time Frame: Baseline vs. day 42
|
Microbiologic assessment of fecal deoxyribonucleic acid (DNA) samples will be obtained before, during and after treatment to quantify the change in microbial alpha diversity using statistical methods such as Shannon Diversity Index and Microbiome Health Index
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Baseline vs. day 42
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of mucosal healing
Time Frame: Baseline vs. Day 42
|
Mucosal biopsies will be taken and assessed.
Assessment will be made using the Mayo Score for Ulcerative Colitis.
There are four domains in this scale: Stool frequency, Rectal bleeding, Findings on endoscopy, Physician's global assessment.
Each domain has a scoring range of 0 - 3, where 0 represents best possible outcome and 3 represents worst possible outcome.
Efficacy of treatment will be defined as a 'Findings on endoscopy' score of less than or equal to one.
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Baseline vs. Day 42
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Inflammatory Bowel Disease Questionnaire
Time Frame: Baseline vs. Day 42
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This is a self-administered questionnaire.
There are 32 quality of life questions related to bowel function.
Each question is rated on a numerical scale.
The number of possible ratings varies between questions but is most frequently from 1 to 7.
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Baseline vs. Day 42
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allan H Steinhart, MD, Mount Sinai Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MET-2-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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