Clinical Research Directory
Browse clinical research sites, groups, and studies.
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Sponsor: University of Nebraska
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.
Official title: Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial
Key Details
Gender
All
Age Range
1 Month - 3 Years
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2026-03
Completion Date
2029-12
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
2 mL SunButyrate-TG
Participants randomized into the 2 milliliter (mL) SunButyrate-TG will take the supplement once daily for 3 weeks prior to cardiac surgery. Note: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated.
Placebo
Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery
4 mL SunButyrate-TG
Participants randomized into the 4 mL SunButyrate-TG arm will take the supplement once daily for 3 weeks prior to cardiac surgery. Note: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated.
Locations (1)
Children's Nebraska, 8200 Dodge St
Omaha, Nebraska, United States