Early Cirrhosis
Conditions
Brief summary
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.
Interventions
OTHERKB174
KB174 is a novel mixture of oligosaccharides.
OTHERMaltodextrin
Maltodextrin is a commercially available easily digestible polysaccharide.
Sponsors
Kaleido Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Be able and willing to provide written informed consent * Be male or female, 18 to 70 years of age (inclusive) * Have a body mass index (BMI) ≥ 20.0 and \< 40.0 kg/m2 * Well-compensated cirrhosis * Negative for hepatocellular carcinoma (HCC) * Adequate safety laboratory values at Screening. * Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine * If of child bearing potential must follow contraceptive requirements of the protocol * Have reliable internet access
Exclusion criteria
* Have evidence of decompensated liver disease. * History or active GI disease. * Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list. * Subject has a history of drug and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 28. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 27. | 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. |
| Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 29. | 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. |
| . Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 29. | 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. |
| Change in ammonia in blood for KB174 compared to Maltodextrin. | Day -3 to Day 43. | Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin |
| Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 29. | 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. |
| Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 29. | 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. |
| Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 29. | 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. |
| Incidence of treatment-emergent adverse events from baseline to end of study. | Day -7 through Day 43 visit. | — |
| Incidence of serious adverse events from base baseline to end of study. | Day -7 through Day 43. | — |
| Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires. | Day -7 through Day 43. | 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. |
| Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires | Day -7 through Day 43. | 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). |
| Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Day -3 to Day 29. | 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. |
Countries
United States
Outcome results
None listed