This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
KB174 is a novel mixture of oligosaccharides.
Maltodextrin is a commercially available easily digestible polysaccharide.
Research Centers of America
Hollywood, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Marquez Clinical Site Partners, LLC Florida Premier Research Institute
Winter Park, Florida, United States
Delta Research Partners
Monroe, Louisiana, United States
Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption.
Time frame: Day -3 to Day 28.
Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N in stool in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post 28-day study compound consumption.
Time frame: Day -3 to Day 29.
Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total nitrogen in blood in response to an amino acid challenge during Baseline \[pre-study compound consumption\] versus post 28-day study compound consumption.
Time frame: Day -3 to Day 27.
Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total nitrogen in urine in response to an amino acid challenge during Baseline \[pre study compound consumption\] versus post 28-day study compound consumption.
Time frame: Day -3 to Day 29.
. Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total nitrogen in stool in response to an amino acid challenge during Baseline \[pre study compound consumption\] versus post 28-day study compound consumption.
Time frame: Day -3 to Day 29.
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Change in ammonia in blood for KB174 compared to Maltodextrin.
Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin
Time frame: Day -3 to Day 43.
Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total urea in urine in response to an amino acid challenge during baseline \[pre study compound consumption\] versus post 28-day compound consumption.
Time frame: Day -3 to Day 29.
Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N-urea in urine in response to an amino acid challenge from baseline \[pre study compound consumption \] versus post 28-day compound consumption.
Time frame: Day -3 to Day 29.
Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N-urea in stool in response to an amino acid challenge from baseline \[pre study compound consumption \] versus post 28-day compound consumption.
Time frame: Day -3 to Day 29.
Incidence of treatment-emergent adverse events from baseline to end of study.
Time frame: Day -7 through Day 43 visit.
Incidence of serious adverse events from base baseline to end of study.
Time frame: Day -7 through Day 43.
Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.
Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions.
Time frame: Day -7 through Day 43.
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires
Evaluate the effect of KB195 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 43.