drugset / Trial / NCT06882772

Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

NCT06882772 ↗

Phase 1/2 Not yet recruiting 105 enrolled University of Nebraska
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2026-03
Primary completion
2029-06
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject SunButyrate-TG Unknown 2 ml —
Subject SunButyrate-TG Unknown 4 ml —