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Encapsulated FMT for VRE Decolonization
NCT03063437Phase 2Completed
- Sponsor
- OpenBiome
- Start
- Aug 2017
- Primary completion
- Sep 2018
- Modality
- Live Biotherapeutic Products
- Countries
- 1
01
Overview
Phase 2, randomised, double-blind trial of allogeneic fecal microbiota in Enterococcus colonization (2 arms), sponsored by OpenBiome. Primary endpoints: Percentage of Participants With VRE Decolonization at Day 10 and Percentage of Participants With an Adverse Event (AE); Severe Adverse Event (SAE); and Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI) at Day 10. Started Aug 2017; status: completed.
02
Drugs
allogeneic fecal microbiota
03
Conditions
Enterococcus colonization
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