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

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

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.

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.