CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Encapsulated fecal microbiota preparation +1 morebiological
Likely dose
30 capsules encapsulated fecal microbiota preparationAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years at enrollment
  • ✓VRE-positive confirmed by stool culture within last 14 days
  • ✓Able to swallow capsules
  • ✓Able to provide written informed consent
Key exclusion· 17
  • ✕Pregnant, lactating, or planning pregnancy during study
  • ✕Unable or unwilling to swallow capsules
  • ✕Active antibiotic-resistant bacteria or GI infection at enrollment
  • ✕Antibiotic use within 48 hours of enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03063437
NCT03063437Phase 2Completed
CompareCT.gov

Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group Trial of Encapsulated Fecal Microbiota Transplantation for Vancomycin Resistant Enterococcus Decolonization

Microbiome Health Research Institute·interventional·Posted Feb 24, 2017·Updated Apr 13, 2020

In Brief

A Phase 2 clinical trial evaluating Encapsulated fecal microbiota preparation and Encapsulated placebo for Antibiotic Resistant Strain. Completed, enrolled 9 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAntibiotic Resistant Strain
CountriesUnited States
CollaboratorsUniversity of Wisconsin, Madison, Indiana University

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 24, 2017
Enrollment StartAug 17, 2017
Primary CompletionSep 19, 2018
Study CompletionFeb 26, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.4 years ago

Interventions

Encapsulated fecal microbiota preparationbiological

30 capsules

Encapsulated placebobiological

30 capsules