Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial
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.
Description
The goal of this study is to supplement a liquid form of butyric acid once daily for 3 weeks prior to cardiac surgery for infants and children, ages 1 month to 3 years, with congenital heart disease to improve their pre-operative gut microbiome in efforts to reduce post-operative gut permeability and reduce post-operative inflammatory signaling. Up to 35 participants will be enrolled in each of three arms: * 2 mL butyric acid * 4 mL butyric acid * Placebo. Participants will be asked to: * Provide blood and stool samples (baseline, post-supplement-pre-operative, 1-hr post-op, \& post-op day…
Eligibility
- Age range
- 0–3 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- Drug2 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.
- DrugPlacebo
Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery
- Drug4 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.
Location
- Children's Nebraska, 8200 Dodge StOmaha, Nebraska