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.
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.
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