Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC)

Ulcerative Colitis Clinical Trial

Official title:

A Phase 1b, Placebo-controlled, Study of the Safety and Efficacy of MET-2 in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832400
• Other study ID #: MET-2-201
• Status: Completed
• Phase: Phase 1
• Start date: February 4, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2020
• Source: NuBiyota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To define the parameters for dose-dependent engraftment of MET-2 commensal bacteria for the treatment of mild to moderate ulcerative colitis

Description:

This study will deliver MET-2 at two different doses via an oral capsule in patients with active mucosal inflammation and observe its safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy as compared to placebo. The goal is to define the parameters for dose-dependent engraftment of MET-2 commensal bacteria for the treatment of mild to moderate ulcerative colitis not fully responsive to conventional therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Mild to Moderate UC.

2. = 18 years old.

3. Able to provide informed consent, or have a caregiver able to provide consent.

4. 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

5. 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.

6. 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.

7. Willing to participate in follow up as part of the study.

Exclusion Criteria:

1. Ulcerative colitis with disease limited to only the distal rectum (<5cm from dentate line).

2. Subjects with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease will be excluded.

3. Subjects with colonic dysplasia or neoplasia. (Subjects with prior history of adenomatous polyps will be eligible if the polyps have been completely removed).

4. Subjects with toxic megacolon or hospitalized for ulcerative colitis.

5. 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.

6. Use of antibiotics within 6 weeks of randomization visit.

7. Allergy to vancomycin.

8. Elective surgery that will require preoperative antibiotics planned within 3 months of enrolment.

9. Pregnant or planning to get pregnant in the next 6 months.

10. Any condition for which, in the opinion of the investigator, the subject should be excluded from the study.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• MET-2
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.

Drug:
• Placebo oral capsule
Placebo oral capsule which is identical to the MET-2 capsules.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
NuBiyota

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiome restoration	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	Baseline vs. day 42
Secondary	Assessment of mucosal healing	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.	Baseline vs. Day 42
Secondary	Inflammatory Bowel Disease Questionnaire	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.	Baseline vs. Day 42