Butyric acid before heart surgery in infants and young kids with CHD
Official title: Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial
Run by University of Nebraska · NCT06882772 · Data updated 2026-11-12
This study tests whether giving butyric acid to infants and children aged 1 month to 3 years before heart surgery is safe and whether it improves gut health and lowers inflammation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Month to 3 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT06882772 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants and children 1 month to 3 years old with congenital heart disease scheduled for cardiac surgery with bypass.
✕Probably not a fit
Patients without gut-related issues or those not showing gut barrier changes may not derive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will give a liquid butyric acid supplement once daily for three weeks before cardiopulmonary bypass surgery in children with congenital heart disease. The trial includes three groups: 2 mL, 4 mL, and placebo, with up to 35 participants per group. They will monitor safety through blood tests and adverse events, and assess gut health by analyzing stool and blood samples for microbiome, metabolites, and gut barrier markers, as well as post-operative inflammatory signals. Samples are collected at baseline, before surgery, and after surgery to track changes. The study aims to identify whether pre-operative butyric acid can favorably modulate the gut environment and reduce post-operative inflammation.
Why it matters
Potential benefit: If successful, the approach could improve gut health and lessen inflammatory responses after surgery in young CHD patients.
How similar studies have gone: Previous adult studies suggest butyric acid can support gut health, and preliminary pediatric data indicate safety in older children, but this exact pre-operative approach in infants is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Children's Nebraska, 8200 Dodge St
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Jeffrey Salomon, MD, MBA — University of Nebraska
- Study coordinator: Jeffrey D Salomon, MD, MBA
- Email: jeffrey.salomon@unmc.edu
- Phone: 940-453-7166
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.