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A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization

NCT03063437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-04-13

Study results available
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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.

Conditions

  • Antibiotic Resistant Strain

Interventions

BIOLOGICAL

Encapsulated fecal microbiota preparation

30 capsules

BIOLOGICAL

Encapsulated placebo

30 capsules

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Microbiome Health Research Institute

    lead OTHER

Principal Investigators

  • Majdi Osman, MD, MPH · Microbiome Health Research Institute d/b/a OpenBiome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-17
Primary Completion
2018-09-19
Completion
2019-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063437 on ClinicalTrials.gov