Trials / Completed
CompletedNCT03660748
Safety and Efficacy of MET-3 in Obese Human Subjects
A Phase I, Open-Label, Single-Centre Study of the Safety and Efficacy of Microbial Ecosystem Therapeutics (MET)-3 in Obese Human Subjects
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- NuBiyota · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A pilot study to explore the metabolic effect and safety of a 3-week course of therapy with MET-3 in obese subjects
Detailed description
This is an open label, single center, uncontrolled pilot study of 20 participants; each group will receive a different dose of MET-3. Each group will have 4-6 females, 4-6 participants with BMI 30.0-34.9 kg/m² and the remainder with BMI 35-39.9 kg/m.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MET-2 | Ingestion of a novel human microbiome preparation |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2020-01-22
- Completion
- 2020-01-22
- First posted
- 2018-09-07
- Last updated
- 2020-08-11
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03660748. Inclusion in this directory is not an endorsement.