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Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial

Who can join

1 Month – 3 Years · All sexes

Inclusion Criteria:

* Infants and Children undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Antibiotics, surgery, or chemotherapy within the past 8 weeks
* Continuous enteral feeds before surgery
* GI pathology or intestinal surgery (excluding G-tube)
* Liver disease with elevated transaminitis or dialysis-dependent renal disease

About the study

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.

What is being tested

• 2 mL SunButyrate-TG (drug)
• Placebo (drug)
• 4 mL SunButyrate-TG (drug)

Sponsor: University of Nebraska · Participants: 105 · Started: Nov 1, 2026

Contact the study team

• Jeffrey D Salomon, MD, MBA · Phone: 940-453-7166

Official record on ClinicalTrials.gov — NCT06882772

Locations in the U.S.

Conditions

• Congenital Heart Defects

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.