Status:
COMPLETED
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Lead Sponsor:
Kaleido Biosciences
Conditions:
Early Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 stru...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03855956
Start Date
February 27 2019
End Date
October 1 2019
Last Update
May 14 2020
Active Locations (4)
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1
Research Centers of America
Hollywood, Florida, United States, 33024
2
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147
3
Marquez Clinical Site Partners, LLC Florida Premier Research Institute
Winter Park, Florida, United States, 32789
4
Delta Research Partners
Monroe, Louisiana, United States, 71201