Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
This study is looking at whether a dietary supplement called SunButyrate-TG, which contains butyric acid, can improve gut health in infants and young children (ages 1 month to 3 years) with congenital heart disease (CHD) who are having heart surgery. Butyric acid is thought to help the gut and its helpful bacteria. Participants will receive either a 2 mL dose of SunButyrate-TG, a 4 mL dose, or a placebo (an inactive oil) once daily for three weeks before their surgery. The main goals are to see if SunButyrate-TG is safe and well-tolerated, and to check for changes in white blood cell counts. The study aims to enroll 105 children.
- Study design
- This is an interventional study where participants are randomly assigned to one of three groups: 2 mL SunButyrate-TG, 4 mL SunButyrate-TG, or a placebo.
- What's involved
- Participants will take a daily supplement for 3 weeks before surgery, provide blood and stool samples at several time points, and keep a daily log of supplement timing and any side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track adverse events for up to 3 years after supplementation.
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Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
At a glance
Conditions
NCT06882772
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Nebraska, 8200 Dodge St
Omaha, Nebraskastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jeffrey Salomon, MD, MBA · PRINCIPAL_INVESTIGATOR · University of Nebraska
Who to contact
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Inclusion
Exclusion
What this trial measures
- Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation3 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-TGBaseline 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 SupplementationBaseline 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-TGBaseline 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-TGBaseline 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-TGBaseline 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).
- Changes in Liver Function with SunButyrate-TGBaseline to 4 months
Investigators will collect blood and measure a comprehensive metabolic panel before and after supplementation for evidence of liver injury. Investigators will determine: 1. Presence of acidosis (pH\< 7.3) 2. Elevation of transaminitis (AST/ALT \> 3 x baseline) 3. Elevation in INR (\>2 if not on coumadin) 4. Elevation in Bilirubin (\>2 mg/dL) 5. Elevation in alkaline phosphatase (\> 2 x baseline) If a participant meets any one of the above criteria, this will be considered evidence of liver injury and reported.
- Improvement in Gut Microbiome as Measured by Alpha Diversity, Shannon Diversity Index and Simpson Diversity Index with SunButyrate-TG SupplementationBaseline to 4 months
Changes to the gut microbiome will be measured before and after supplementation, as well as post-operatively. Investigators will measure improvement in alpha diversity and the number of short-chain fatty acids (SCFA) producing bacterial populations. An improvement will be classified by an increase in alpha diversity of measurable OTU's by 12, Shannon diversity index (increase of 0.5), and Simpson diversity index (increase of 0.08), and specific number of SCFA producing organisms by 5 OTU's compared to the placebo group.
- Changes in Short-Chain Fatty Acids with SunButyrate-TGBaseline to 4 months
Investigators will measure metabolite profiles to evaluate the amount of short-chain fatty acids (SCFA) in the gut and plasma before and after supplementation with SunButyrate-TG. This will be classified by a statistically significant increase (p\<0.05) in a list of 8 different SCFA. A positive increase in SCFA production will be classified by at least 1 SCFA being significantly increased following supplementation with SunButyrate-TG compared to the placebo group.
- Gut Barrier Function after SunButyrate-TGBaseline to 4 months
Investigators will measure 3 plasma markers of intestinal barrier function between pre- and post-supplement, as well as post-operatively. These markers are claudin-2, claudin-3, and intestinal fatty acid binding protein (FABP2). An improvement in gut barrier will be considered if there is a statistically significant reduction in the plasma marker of any of these at the post-supplementation, or post-operative time points compared to the placebo group.