Clinical Trial

Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

Study acronym: BASICS-Kids
Not Yet Recruiting Phase 1/2
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Summary
Butyric acid has been shown to promote gut health and improve the microbiome in multiple adult studies. In preliminary studies in older children with inflammatory bowel disease, butyric acid was shown to be safe. However, it's suitability for infants and young children with congenital heart disease (CHD) has yet to be determined. This study will examine butyric acid supplementation in infants and children, ages 1 month to 3 years, with CHD who require cardiac surgery with cardiopulmonary bypass. Study goals include determining the safety and tolerability of butyric acid supplementation before cardiac surgery, and to identify changes in gut microbial communities, metabolic profile, and genetic markers intestinal function. Also, the study seeks to establish a reduction in inflammation (inflammatory signaling) after cardiopulmonary bypass (CPB) in participants receiving butyric acid.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-14.
Trial Details
NCT Number NCT06882772
Lead Sponsor University of Nebraska
Conditions Congenital Heart Disease (CHD)
Enrollment 105 participants
Start Date 2026-03
Primary Completion 2029-06 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-24