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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: NuBiyota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-04
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2019-02-06
• Last updated: 2021-05-03

Locations

1 site across 1 country: Canada