VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms
NCT03944369 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2021-01-22
Summary
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized with multiple drug-resistant organisms.
Conditions
- Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
Interventions
- OTHER
-
KB109
KB109 is a novel glycan
- OTHER
-
No intervention
No intervention
Sponsors & Collaborators
-
Kaleido Biosciences
lead INDUSTRY
Principal Investigators
-
Mark Wingertzahn, PhD · Kaleido Boisciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-27
- Primary Completion
- 2020-06-16
- Completion
- 2020-06-16
Countries
- United States
Study Locations
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