Butyric Acid for Gut Improvement After Heart Surgery in Kids
(BASICS-Kids Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJeffrey Salomon, MD, MBA

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Nebraska

Trial Summary

What is the purpose of 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

This trial is for infants and children from 1 month to 3 years old with congenital heart disease (CHD) who need heart surgery involving cardiopulmonary bypass. They shouldn't have had antibiotics, surgery, or chemotherapy in the last 8 weeks, continuous enteral feeds before surgery, any GI pathology or intestinal surgeries (except G-tube), or severe liver or kidney disease.

Inclusion Criteria

My child is having heart surgery with a heart-lung machine.

Exclusion Criteria

I haven't had antibiotics, surgery, or chemotherapy in the last 8 weeks.

I have been on a feeding tube before surgery.

I have had GI surgery or a problem with my intestines, but not a G-tube.

+1 more

Participant Groups

The study tests if butyric acid supplements can improve gut health in these young patients. It will compare two doses of SunButyrate-TG against a placebo to see how they affect the gut microbiome, metabolism, genetic markers of intestinal function, and inflammation after heart surgery.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 4 mL SunButyrate-TG (Arm 2)Experimental Treatment1 Intervention

Participants will receive 4 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.

Group II: 2 mL SunButyrate-TG (Arm1)Experimental Treatment1 Intervention

Participants will receive 2 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.

Group III: Placebo Comparator (Arm 3)Placebo Group1 Intervention

Participants will receive either 2 milliliter (mL) or 4 mL of an inactive oil-based placebo once daily for 3 weeks prior to cardiac surgery.