Congenital Heart Disease (CHD)Phase 1/2BASICS-KidsNCT06882772
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
A Phase 1/2 study testing 2 mL SunButyrate-TG and 4 mL SunButyrate-TG in people with Congenital Heart Disease (CHD), run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- 2 mL SunButyrate-TG and 4 mL SunButyrate-TG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and Children undergoing cardiac surgery with cardiopulmonary bypass
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Nebraska, 8200 Dodge St
Omaha, Nebraska, 68114
Jeffrey D Salomon, MD, 402-955-4264, jeffrey.salomon@unmc.edu
About this study
Official title: Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial
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.
Read the detailed description
The goal of this study is to supplement a liquid form of butyric acid once daily for 3 weeks prior to cardiac surgery for infants and children, ages 1 month to 3 years, with congenital heart disease to improve their pre-operative gut microbiome in efforts to reduce post-operative gut permeability and reduce post-operative inflammatory signaling.
Up to 35 participants will be enrolled in each of three arms:
- 2 mL butyric acid
- 4 mL butyric acid
- Placebo.
Participants will be asked to:
- Provide blood and stool samples (baseline, post-supplement-pre-operative, 1-hr post-op, \& post-op days 1-3)
- Take either 2 mL, 4 mL or placebo once daily for 3 weeks prior to cardiac surgery
- Complete a daily log to track timing of supplement administration and any side effects or adverse events experienced
Study aims:
- Aim 1 Safety and tolerability will be measured following baseline complete blood counts, complete metabolic panel to evaluate electrolytes and organ function, along with a daily log of supplementation timing and any experienced adverse events.
- Aim 2 Modulation of gut health will be measured with stool and blood samples. Changes will be measured in the gut microbiome and metabolite profiles before and after supplementation, as well as post-operatively. Gut health will be determined by measuring plasma markers of gut barrier function before and after supplementation, as well as post-operatively.
- Aim 3 Reduction of post-operative inflammatory signaling will be measured with blood samples. Plasma cytokine levels, immune cell profiles, and inflammatory gene activation with an RNA hybridization panel will be measured pre-operatively and post-operatively.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- 2 mL SunButyrate-TG, Placebo, 4 mL SunButyrate-TG
- Keywords
- Congenital Heart Disease, Gut Health, Microbiome, Gut Barrier Function, Inflammation
- Medical subject headings
- Heart Defects, Congenital, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mL SunButyrate-TGDrug
Also called Butyrate Liquid Supplement
Participants randomized into the 2 milliliter (mL) SunButyrate-TG will take the supplement once daily for 3 weeks prior to cardiac surgery.
Note: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated.
PlaceboDrug
Also called sugar pill
Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery
4 mL SunButyrate-TGDrug
Also called Butyrate Liquid Supplement
Participants randomized into the 4 mL SunButyrate-TG arm will take the supplement once daily for 3 weeks prior to cardiac surgery.
Note: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated.
| Study group | Role | What they receive |
|---|---|---|
| 2 mL SunButyrate-TG (Arm1) | Experimental | Participants will receive 2 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery. Receives: Drug: 2 mL SunButyrate-TG |
| 4 mL SunButyrate-TG (Arm 2) | Experimental | Participants will receive 4 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery. Receives: Drug: 4 mL SunButyrate-TG |
| Placebo Comparator (Arm 3) | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation
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.
Measured: 3 years
Tolerance of SunButyrate-TG
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.
Measured: Baseline to 3 weeks
Changes to White Blood Cell Count with SunButyrate-TG Supplementation
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.
Measured: Baseline to 3 weeks
Changes to Hematocrit with SunButyrate-TG
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.
Measured: Baseline to 3 weeks
Changes in Platelets with SunButyrate-TG
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.
Measured: Baseline to 3 weeks
Changes to Renal Function (BUN, Creatinine or urine output) with SunButyrate-TG
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).
Measured: Baseline to 4 months
Changes in Liver Function with SunButyrate-TG
Investigators will collect blood and measure a comprehensive metabolic panel before and after supplementation for evidence of liver injury. Investigators will determine:
- Presence of acidosis (pH< 7.3)
- Elevation of transaminitis (AST/ALT > 3 x baseline)
- Elevation in INR (>2 if not on coumadin)
- Elevation in Bilirubin (>2 mg/dL)
- 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.
Measured: Baseline to 4 months
Improvement in Gut Microbiome as Measured by Alpha Diversity, Shannon Diversity Index and Simpson Diversity Index with SunButyrate-TG Supplementation
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.
Measured: Baseline to 4 months
Changes in Short-Chain Fatty Acids with SunButyrate-TG
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.
Measured: Baseline to 4 months
Gut Barrier Function after SunButyrate-TG
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.
Measured: Baseline to 4 months
Secondary outcomes (5)
Reduction of Post-Operative Cytokine Values
Investigators will measure cytokine levels pre- and post-surgery to determine changes in cytokine profiles of a panel of 8 different cytokines, including TNF-alpha, IL-1, IL-4, IL-6, IL-7, IL-8, IL-10, TGF-beta and IFN-gamma). An improvement in the cytokine profile will be considered if there is a statistically significant reduction in pro-inflammatory cytokines (IL-1, TNFa, IL-6, IL-4, or IL-8, IFN-gamma) or a significant increase in anti-inflammatory cytokines (IL-10 and TGF-beta) compared to the placebo group. These cytokines are measured together and will be considered a positive improvement in cytokine profiles if at least 2 pro-inflammatory cytokine values are reduced in conjunction with an increase in IL-10 and/or TGF-beta.
Measured: Pre-surgery to 4 days post-operatively
Changes in Neutrophils After Surgery with SunButyrate-TG
Investigators will evaluate immune cell profiles in participants before and after surgery. Investigators will evaluate shifts in neutrophils. A significant change will be considered if there is a reduction of greater than 5% total neutrophil count via flow cytometry.
Measured: Pre-surgery to 4 days post-operatively
Changes in Macrophages After Surgery with SunButyrate-TG
Investigators will evaluate immune cell profiles in participants before and after surgery. Investigators will evaluate shifts in macrophages. A significant change will be considered if there is a reduction of greater than 5% total macrophage count via flow cytometry.
Measured: Pre-surgery to 4 days post-operatively
Changes in T-regulatory Cells After Surgery with SunButyrate-TG
Investigators will evaluate immune cell profiles in participants before and after surgery. Investigators will evaluate shifts in T-regulatory cells (T-cell). A significant change will be considered if there is an increase of greater than 10% in T-regulatory cell count via flow cytometry.
Measured: Pre-surgery to 4 days post-operatively
Changes in Natural Killer T-cells Cells After Surgery with SunButyrate-TG
Investigators will evaluate immune cell profiles in participants before and after surgery. Investigators will evaluate shifts in natural killer T-cells (NK T-cell). A significant change will be considered if there is a reduction of greater than 10% total NK T-cell count via flow cytometry.
Measured: Pre-surgery to 4 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Salomon, University of Nebraska
- Investigators
- Jeffrey Salomon, MD, MBA, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882772
- Sponsor's protocol ID
- 0839-24-FB
- Other IDs
- 11543
- Acronym
- BASICS-Kids
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant information will be partially de-identified. Information related to age, gender, ethnicity, and cardiac lesion will be shared. Additional information regarding the cardiac surgery, Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) category, and lab values will also be included.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial
- ClinicalTrials.gov ID
- NCT06882772
- Acronym / sponsor ID
- BASICS-Kids / 0839-24-FB
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- Congenital Heart Disease, Gut Health, Microbiome, Gut Barrier Function, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to supplement a liquid form of butyric acid once daily for 3 weeks prior to cardiac surgery for infants and children, ages 1 month to 3 years, with congenital heart disease to improve their pre-operative gut microbiome in efforts to reduce post-operative gut permeability and reduce post-operative inflammatory signaling.
Up to 35 participants will be enrolled in each of three arms:
- 2 mL butyric acid
- 4 mL butyric acid
- Placebo.
Participants will be asked to:
- Provide blood and stool samples (baseline, post-supplement-pre-operative, 1-hr post-op, \& post-op days 1-3)
- Take either 2 mL, 4 mL or placebo once daily for 3 weeks prior to cardiac surgery
- Complete a daily log to track timing of supplement administration and any side effects or adverse events experienced
Study aims:
- Aim 1 Safety and tolerability will be measured following baseline complete blood counts, complete metabolic panel to evaluate electrolytes and organ function, along with a daily log of supplementation timing and any experienced adverse events.
- Aim 2 Modulation of gut health will be measured with stool and blood samples. Changes will be measured in the gut microbiome and metabolite profiles before and after supplementation, as well as post-operatively. Gut health will be determined by measuring plasma markers of gut barrier function before and after supplementation, as well as post-operatively.
- Aim 3 Reduction of post-operative inflammatory signaling will be measured with blood samples. Plasma cytokine levels, immune cell profiles, and inflammatory gene activation with an RNA hybridization panel will be measured pre-operatively and post-operatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 mL SunButyrate-TG (Arm1) | Experimental | Drug: 2 mL SunButyrate-TGParticipants will receive 2 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery. |
| 4 mL SunButyrate-TG (Arm 2) | Experimental | Drug: 4 mL SunButyrate-TGParticipants will receive 4 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery. |
| Placebo Comparator (Arm 3) | Placebo comparator | Drug: PlaceboParticipants will receive either 2 milliliter (mL) or 4 mL of an inactive oil-based placebo once daily for 3 weeks prior to cardiac surgery. |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants and Children undergoing cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 mL SunButyrate-TGAlso: Butyrate Liquid SupplementParticipants randomized into the 2 milliliter (mL) SunButyrate-TG will take the supplement once daily for 3 weeks prior to cardiac surgery. Note: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated. | Drug | 2 mL SunButyrate-TG (Arm1) |
| PlaceboAlso: sugar pillParticipants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery | Drug | Placebo Comparator (Arm 3) |
| 4 mL SunButyrate-TGAlso: Butyrate Liquid SupplementParticipants randomized into the 4 mL SunButyrate-TG arm will take the supplement once daily for 3 weeks prior to cardiac surgery. Note: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated. | Drug | 4 mL SunButyrate-TG (Arm 2) |
Primary outcome
Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Changes in Liver Function with SunButyrate-TG
Time frame: Baseline 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 Supplementation
Time frame: Baseline 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-TG
Time frame: Baseline 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-TG
Time frame: Baseline 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.
5 secondary outcomes
Reduction of Post-Operative Cytokine Values
Time frame: Pre-surgery to 4 days post-operatively
Changes in Neutrophils After Surgery with SunButyrate-TG
Time frame: Pre-surgery to 4 days post-operatively
Changes in Macrophages After Surgery with SunButyrate-TG
Time frame: Pre-surgery to 4 days post-operatively
Changes in T-regulatory Cells After Surgery with SunButyrate-TG
Time frame: Pre-surgery to 4 days post-operatively
Changes in Natural Killer T-cells Cells After Surgery with SunButyrate-TG
Time frame: Pre-surgery to 4 days post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Participant information will be partially de-identified. Information related to age, gender, ethnicity, and cardiac lesion will be shared. Additional information regarding the cardiac surgery, Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) category, and lab values will also be included.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Salomon, MD, MBA principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 2 mL SunButyrate-TG and 4 mL SunButyrate-TG in people with Congenital Heart Disease (CHD), run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey D Salomon, MD, MBA (940-453-7166, jeffrey.salomon@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation (time frame: 3 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.