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NCT03855956 · ClinicalTrials.gov registry record · NA
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
A NA study of Early Cirrhosis, sponsored by Kaleido Biosciences.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT03855956: Completed NA study of Early Cirrhosis, sponsored by Kaleido Biosciences.
NCT03855956 is a NA study of Early Cirrhosis that has completed, run by Kaleido Biosciences. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03855956, a NA study of Early Cirrhosis, has completed, sponsored by Kaleido Biosciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study 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 structure and function in subjects with well-compensated cirrhosis.
Primary Outcome
Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption.
Conditions Studied
Interventions
- OTHER Maltodextrin
- OTHER KB174
Study Locations (4)
Florida
- Research Centers of America - Hollywood
- Advanced Pharma CR, LLC - Miami
- Marquez Clinical Site Partners, LLC Florida Premier Research Institute - Winter Park
Louisiana
- Delta Research Partners - Monroe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2019-10-01 |
| Phase | NA |
What the finished NCT03855956 record still lists
NCT03855956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Early Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Maltodextrin is the first listed.
NCT03855956 reports a single indexed study location in Florida, Louisiana.
Frequently Asked Questions
What is clinical trial NCT03855956 about?
NCT03855956 is a clinical study titled "Clinical Food Study to Evaluate the Effect of KB174 on 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.
What is the current status of trial NCT03855956?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-02-27. Estimated completion is 2019-10-01.
What conditions does trial NCT03855956 study?
This clinical trial studies the following conditions: Early Cirrhosis.
What interventions are being tested in trial NCT03855956?
The interventions under investigation include: Maltodextrin (OTHER), KB174 (OTHER).
Who is sponsoring clinical trial NCT03855956?
This trial is sponsored by Kaleido Biosciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03855956 being conducted?
This trial has 4 study locations across Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03855956's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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