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.
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Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation
Timeframe: 3 years
Tolerance of SunButyrate-TG
Timeframe: Baseline to 3 weeks
Changes to White Blood Cell Count with SunButyrate-TG Supplementation
Timeframe: Baseline to 3 weeks
Changes to Hematocrit with SunButyrate-TG
Timeframe: Baseline to 3 weeks
Changes in Platelets with SunButyrate-TG
Timeframe: Baseline to 3 weeks
Changes to Renal Function (BUN, Creatinine or urine output) with SunButyrate-TG
Timeframe: Baseline to 4 months
Changes in Liver Function with SunButyrate-TG
Timeframe: Baseline to 4 months
Improvement in Gut Microbiome as Measured by Alpha Diversity, Shannon Diversity Index and Simpson Diversity Index with SunButyrate-TG Supplementation
Timeframe: Baseline to 4 months
Changes in Short-Chain Fatty Acids with SunButyrate-TG
Timeframe: Baseline to 4 months
Gut Barrier Function after SunButyrate-TG
Timeframe: Baseline to 4 months