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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
3
KB109 is a novel glycan
No intervention
Harbor UCLA Medical Center
Torrance, California, United States
Emory University
Atlanta, Georgia, United States
Augusta Universtiy
Augusta, Georgia, United States
Newland Immunology Center of Excellence; Providence Hospital
Incidence of product-related treatment-emergent adverse events (TEAEs)
Time frame: Day -7 through Day 42
Incidence of serious adverse events (SAEs)
Time frame: Day -7 through Day 42
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires.
Evaluate the effect of KB109 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid)
Time frame: Day -7 through Day 42]
1. Proportion of subjects with a reduction from baseline on Day 28 in the relative abundance of taxa of interest (Enterobacteriaceae, Enterococcus, and C. difficile, individually) as measured by metagenomic sequencing.
Time frame: Day -1 to Day 28
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Southfield, Michigan, United States
Stony Brook University
Stony Brook, New York, United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States