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

Status:	Recruiting
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 70
Updated:	3/17/2019
Start Date:	February 27, 2019
End Date:	February 2020
Contact:	Margaret Koziel, MD
Email:	info@kaleido.com
Phone:	617-674-9000

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.

We found this trial at

sites

Delta Research Partners, LLC

Monroe, Louisiana 71201

Phone: 318-281-6040

from

Monroe, LA