Trials / Completed
CompletedNCT03063437
A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization
Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group Trial of Encapsulated Fecal Microbiota Transplantation for Vancomycin Resistant Enterococcus Decolonization
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Microbiome Health Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to provide preliminary insight into the safety and efficacy of fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of vancomycin-resistant Enterococcus.
Detailed description
Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Encapsulated fecal microbiota preparation | 30 capsules |
| BIOLOGICAL | Encapsulated placebo | 30 capsules |
Timeline
- Start date
- 2017-08-17
- Primary completion
- 2018-09-19
- Completion
- 2019-02-26
- First posted
- 2017-02-24
- Last updated
- 2020-04-13
- Results posted
- 2020-02-05
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03063437. Inclusion in this directory is not an endorsement.