Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Controlled, Clinical Food Study to Evaluate the Effect of KB174 Compared to an Easily Digestible Polysaccharide on Function and Structure of the Gut Microbiome in Subjects With Well-compensated Cirrhosis

Conditions
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Early Cirrhosis

Intervention / Treatment
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* Other: KB174
* Other: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KB174 Arm<br>KB174 is a novel mixture of oligosaccharides. | Other: KB174<br>* KB174 is a novel mixture of oligosaccharides.<br>|
| Other: Maltodextrin Arm<br>Maltodextrin is a commercially available easily digestible polysaccharide. | Other: Maltodextrin<br>* Maltodextrin is a commercially available easily digestible polysaccharide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day -3 to Day 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Day -3 to Day 29. | 
| 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 | 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. | 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. | 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. | Day -3 to Day 29. | 
| 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. | 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. | 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). | Day -7 through Day 43. |