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- K017-119 VITORA: A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Clinical Food Study to Assess the Safety, Tolerability, and Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts are Colonized with Multiple Drug-resistant Organisms
Clinical Trial
K017-119 VITORA: A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Clinical Food Study to Assess the Safety, Tolerability, and Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts are Colonized with Multiple Drug-resistant Organisms
This study will see how safe and well-tolerated the study product (a food) KB109 is, and how it affects the frequency of development of antibiotic-resistant enterococcus in the gut.
- Digestive System
- Carbapenem-resistant Enterobacteriaceae (CRE)
- Enterococcus
- Extended-spectrum Beta Lactamase-producing Enterobacteriaceae (ESBLE)
- Vancomycin-resistant Enterococcus (VRE)
Eligibility Criteria
- INCLUSION: 1. Stool culture positive for enterococcus 2. Not requiring hospitalization EXCLUSION: 1. Lab values outside of ranges accetable for the study 2. No current or previous medical conditions not allowed by the study 3. No use of another investigational product within 30 days before Screening Visit.
RESEARCH. INNOVATION. DISCOVERY.