Recruiting soon

BASICS-KidsButyric Acid for Gut Health in Children Undergoing Cardiac Surgery

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What is being tested

2 mL SunButyrate-TG

+ Placebo

+ 4 mL SunButyrate-TG

Drug
Who is being recruted

Congenital Abnormalities+6

+ Cardiovascular Diseases

+ Heart Defects, Congenital

From 1 Months to 3 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorUniversity of Nebraska
Study ContactJeffrey D Salomon, MD, MBA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2025

Actual date on which the first participant was enrolled.

The study explores the use of butyric acid in a liquid form to help improve gut health in infants and young children, aged 1 month to 3 years, who have congenital heart disease and are scheduled for cardiac surgery. The aim is to see if taking this supplement daily for three weeks before surgery can make the gut healthier, potentially reducing issues like gut permeability and inflammation after the surgery. This is important because reducing these complications could lead to better recovery and outcomes for children undergoing heart surgery. In the study, participants will be assigned to one of three groups: one taking 2 mL of butyric acid, another taking 4 mL, and a third taking a placebo, all once a day for three weeks before their surgery. They will provide blood and stool samples at various times to check for changes in their gut health and inflammation levels. Participants will also keep a daily log to record when they take the supplement and any side effects. The study will measure the supplement's safety and its effects on gut health and inflammation by analyzing these samples and logs.

Official TitleButyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial
NCT06882772
Principal SponsorUniversity of Nebraska
Study ContactJeffrey D Salomon, MD, MBA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

105 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 Months to 3 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesHeart Defects, CongenitalHeart DiseasesInflammationCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular Abnormalities

Criteria

1 inclusion criteria required to participate
Infants and Children undergoing cardiac surgery with cardiopulmonary bypass

4 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
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.

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Children's Nebraska, 8200 Dodge St

Omaha, United StatesOpen Children's Nebraska, 8200 Dodge St in Google Maps
Recruiting soonOne Study Center