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Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial (BASICS-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 (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.
Details
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 105 |
| Start date | 2026-03 |
| Completion | 2029-12 |
Conditions
- Congenital Heart Disease (CHD)
Interventions
- 2 mL SunButyrate-TG
- Placebo
- 4 mL SunButyrate-TG
Primary outcomes
- Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation — 3 years
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 and SAE definitions used according to FDA regulations. A scoring system of 1-5 will be used to determine the severity of the AE after review by the DSMB. A cumulative score of 3 or greater will require cessation of the study for that individual. If an accumulation of 20 participants or more have a score \>3 the study will be stopped. If an accumulation of SAE (score of 5) in 8 or more participants, the study will be stopped. - Tolerance of SunButyrate-TG — Baseline to 3 weeks
Tolerance will be measured by the incidence of nausea, inability to consume the supplement, or parental concern of intolerance. The tolerance scoring metric will be used to aggregate the listed criteria into a score for each participant. Each characteristic will receive a point. If a participant has a score of 2 or greater, it will be defined as intolerance. Participant study continuation will be discussed with the family in weekly calls during the supplementation period. - Changes to White Blood Cell Count with SunButyrate-TG Supplementation — Baseline to 3 weeks
Safety will be evaluated through measurement of the white blood cell (WBC) count of the complete blood cell (CBC) count. Investigators will evaluate changes between the pre- and post-supplementation period CBC looking at changes in WBC count to quantify the incidence of leukocytosis (WBC \> 15.0 x 10\^9/L) and leukopenia (WBC \< 6.0 x 10\^9/L) after completing the supplement and prior to the surgery. Any participant that has a WBC count higher or lower than the values stated above will be documented. - Changes to Hematocrit with SunButyrate-TG — Baseline to 3 weeks
Investigators will measure hematocrit between pre- and post-supplement time points to determine the effect of SunButyrate-TG. Investigators will evaluate changes between the pre- and post-supplementation period complete blood count (CBC) looking at changes in of anemia (hematocrit \< 29%) or polycythemia (hematocrit \> 45%) after completing the supplement and prior to the surgery. Any participant that has a hematocrit higher or lower than the values stated above will be documented. - Changes in Platelets with SunButyrate-TG — Baseline to 3 weeks
Safety will be evaluated through measurement of the white blood cell (WBC) count of the complete blood cell (CBC) count. Investigators will evaluate changes between the pre- and post-supplementation period complete blood count looking at changes in platelet (PLT) count to quantify the incidence of thrombocytopenia (PLT \< 30 x 10\^9/L) or thrombocythemia (PLT \> 750 x 10\^9/L). Any participant that has a PLT count higher or lower than the values stated above will be documented. - Changes to Renal Function (BUN, Creatinine or urine output) with SunButyrate-TG — Baseline to 4 months
Investigators will collect blood for a comprehensive metabolic panel before and after supplementation with SunButyrate-TG. Investigators will evaluate the changes in blood urea nitrogen (BUN) and Creatinine to determine evidence of renal impairment or acute kidney injury based upon Kidney Disease: Improving Global Outcomes (KDIGO) criteria (creatinine increase 1.5-1.9 times baseline or \>0.3 mg/dL increase), or urine output \< 0.5 mL/kg/h for 6-12 hours (excluding overnight for potty-trained children).
Countries
United States