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

Use our guide to learn which trials are right for you!

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
3
sites
Miami, Florida 33175
Phone: 305-220-2727
?
mi
from
Miami, FL
Click here to add this to my saved trials
7261 Sheridan Street
Hollywood, Florida 33024
Phone: 954-990-7649
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Monroe, Louisiana 71201
Phone: 318-281-6040
?
mi
from
Monroe, LA
Click here to add this to my saved trials