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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2019-10-01

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.

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Detailed Description

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Conditions

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Early Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KB174 Arm

KB174 is a novel mixture of oligosaccharides.

Group Type EXPERIMENTAL

KB174

Intervention Type OTHER

KB174 is a novel mixture of oligosaccharides.

Maltodextrin Arm

Maltodextrin is a commercially available easily digestible polysaccharide.

Group Type OTHER

Maltodextrin

Intervention Type OTHER

Maltodextrin is a commercially available easily digestible polysaccharide.

Interventions

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KB174

KB174 is a novel mixture of oligosaccharides.

Intervention Type OTHER

Maltodextrin

Maltodextrin is a commercially available easily digestible polysaccharide.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No