Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Congenital Heart Disease (CHD)

In brief

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.

Key facts

Study ID

NCT06882772

Run by

University of Nebraska

People needed

105

Starts

2026-03-01

Expected to finish

2029-12-01

Last updated by the study team

2026-02-24

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants and Children undergoing cardiac surgery with cardiopulmonary bypass

You may not qualify if…

• 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

Where it is running

• Children's Nebraska, 8200 Dodge St — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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