Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06882772
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Congenital Heart Disease (CHD)

Eligibility Criteria

Sex
ALL
Age
1 Month - 3 Years
Healthy Volunteers
Not accepted

Interventions

  • 2 mL SunButyrate-TG — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2025
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 2 mL SunButyrate-TG (Arm1)
    Participants will receive 2 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.
  • Experimental: 4 mL SunButyrate-TG (Arm 2)
    Participants will receive 4 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.
  • Placebo Comparator: Placebo Comparator (Arm 3)
    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.

Primary Outcome Measure

Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Nebraska, 8200 Dodge StOmahaNebraska68114
Jeffrey D Salomon, MD
[email protected]
402-955-4264

Find similar trials in Omaha, NE

By research site
Children's Nebraska, 8200 Dodge St· Omaha, NE

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