Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-3
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

Qualifiers

Infants and Children undergoing cardiac surgery with cardiopulmonary bypass

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 2 mL SunButyrate-TG
  • Placebo
  • 4 mL SunButyrate-TG

Treatment groups

105 Participants
are divided into 3 treatment groups

Sponsors and collaborators