Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

December 31, 2028

Conditions
Congenital Heart Disease (CHD)
Interventions
DRUG

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."

DRUG

Placebo

Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery

DRUG

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."

Trial Locations (1)

68114

Children's Nebraska, 8200 Dodge St, Omaha

All Listed Sponsors
lead

University of Nebraska

OTHER

NCT06882772 - Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids | Biotech Hunter | Biotech Hunter