Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Completed · Not applicable
Conditions studied: Early Cirrhosis
In brief
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.
Key facts
- Study ID
- NCT03855956
- Run by
- Kaleido Biosciences
- People needed
- 40
- Starts
- 2019-02-27
- Expected to finish
- 2019-10-01
- Last updated by the study team
- 2020-05-14
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Research Centers of America — Hollywood, Florida, United States
- Advanced Pharma CR, LLC — Miami, Florida, United States
- Marquez Clinical Site Partners, LLC Florida Premier Research Institute — Winter Park, Florida, United States
- Delta Research Partners — Monroe, Louisiana, United States
Full record on ClinicalTrials.gov
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