Recruiting
Phase 1
Phase 2

Butyric Acid

Sponsor:

University of Nebraska

Code:

NCT06882772

Conditions

Congenital Heart Disease (CHD)

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

2 mL SunButyrate-TG

Placebo

4 mL SunButyrate-TG

Study Details

Brief 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.

Conditions

Congenital Heart Disease (CHD)

Study ID

NCT06882772

Start date

Nov 1, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation [ Time Frame: 3 years ]
  • Tolerance of SunButyrate-TG [ Time Frame: Baseline to 3 weeks ]
  • Changes to White Blood Cell Count with SunButyrate-TG Supplementation [ Time Frame: Baseline to 3 weeks ]
  • Changes to Hematocrit with SunButyrate-TG [ Time Frame: Baseline to 3 weeks ]
  • Changes in Platelets with SunButyrate-TG [ Time Frame: Baseline to 3 weeks ]
  • Changes to Renal Function (BUN, Creatinine or urine output) with SunButyrate-TG [ Time Frame: Baseline to 4 months ]
  • Changes in Liver Function with SunButyrate-TG [ Time Frame: Baseline to 4 months ]
  • Improvement in Gut Microbiome as Measured by Alpha Diversity, Shannon Diversity Index and Simpson Diversity Index with SunButyrate-TG Supplementation [ Time Frame: Baseline to 4 months ]
  • Changes in Short-Chain Fatty Acids with SunButyrate-TG [ Time Frame: Baseline to 4 months ]
  • Gut Barrier Function after SunButyrate-TG [ Time Frame: Baseline to 4 months ]

Central Contacts and Locations

Central contacts

Jeffrey D Salomon, MD, MBA

940-453-7166jeffrey.salomon@unmc.edu

Locations

Children's Nebraska, 8200 Dodge St

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Jeffrey D Salomon, MD

402-955-4264jeffrey.salomon@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Oct 30, 2026

Last verified

Jul, 2026

Keywords

  • Congenital Heart Disease
  • Gut Health
  • Microbiome
  • Gut Barrier Function
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.