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NCT06882772 · ClinicalTrials.gov registry record · Phase 1
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
A Phase 1 study, sponsored by University of Nebraska.
- Not yet
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
NCT06882772: Clinical Trial Phase 1 study, sponsored by University of Nebraska.
NCT06882772 is a Phase 1 study that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06882772, a Phase 1 study, has not yet begun recruiting, sponsored by University of Nebraska.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
Study 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.
Primary Outcome
Safety will be measured by the combined incidence of adverse events (AE) and serious adverse events (SAE). These include allergic reaction, vomiting, diarrhea, abdominal distention, infection, hospitalization, or any other concern the families report. A Data Safety Monitoring Board (DSMB) will review and catalog the incidence and severity to determine study continuation. Investigators will evaluate each AE/SAE to determine the safety of the supplement in this age and participant population. AE a
Interventions
- DRUG Placebo
- DRUG 2 mL SunButyrate-TG
- DRUG 4 mL SunButyrate-TG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2026-03 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
What is known before NCT06882772 opens enrollment
NCT06882772 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06882772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06882772 about?
NCT06882772 is a clinical study titled "Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids". 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 ...
What is the current status of trial NCT06882772?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2026-03. Estimated completion is 2029-12.
What interventions are being tested in trial NCT06882772?
The interventions under investigation include: Placebo (DRUG), 2 mL SunButyrate-TG (DRUG), 4 mL SunButyrate-TG (DRUG).
Who is sponsoring clinical trial NCT06882772?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06882772's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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