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

Kaleido Biosciences

Status

Completed

Conditions

Early Cirrhosis

Treatments

Other: KB174

Other: Maltodextrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03855956

K022-118

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.