Butyric Acid for Gut Improvement After Heart Surgery in Kids

(BASICS-Kids Trial)

Overseen By Jeffrey D Salomon, MD, MBA

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Nebraska

Must not be taking: Antibiotics, Chemotherapy

Disqualifiers: Continuous enteral feeds, GI pathology, others

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

Trial Summary

What is the purpose of this 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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have taken antibiotics, had surgery, or undergone chemotherapy in the past 8 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment Butyric Acid for gut improvement after heart surgery in kids?

Research shows that butyric acid, a short-chain fatty acid, helps improve gut health by reducing inflammation and promoting healing in the intestines. It is used to treat various gut issues, suggesting it might help kids recover better after heart surgery by supporting their gut health. ^{1 2 3 4 5}

Is butyric acid safe for use in humans?

Butyric acid is generally considered safe and is used for treating various gut-related issues, but high concentrations can cause inflammation in animal studies. It is a natural product of gut bacteria and is important for gut health, but its effects can vary depending on the dose and method of administration. ^{1 3 6 7 8}

How is the treatment Butyric Acid unique for improving gut health after heart surgery in kids?

Butyric Acid is unique because it is a short-chain fatty acid that serves as a primary energy source for colon cells, helping to improve gut health by supporting intestinal adaptation and enhancing nutrient absorption, which is particularly beneficial after surgery. ^{1 3 5 9 10}

Research Team

Jeffrey Salomon, MD, MBA

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for infants and children from 1 month to 3 years old with congenital heart disease (CHD) who need heart surgery involving cardiopulmonary bypass. They shouldn't have had antibiotics, surgery, or chemotherapy in the last 8 weeks, continuous enteral feeds before surgery, any GI pathology or intestinal surgeries (except G-tube), or severe liver or kidney disease.

Inclusion Criteria

My child is having heart surgery with a heart-lung machine.

Exclusion Criteria

I haven't had antibiotics, surgery, or chemotherapy in the last 8 weeks.

I have been on a feeding tube before surgery.

I have had GI surgery or a problem with my intestines, but not a G-tube.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Supplementation

Participants receive butyric acid or placebo supplementation once daily for 3 weeks prior to cardiac surgery

3 weeks

Weekly calls for monitoring

Surgery and Immediate Post-operative Monitoring

Participants undergo cardiac surgery with cardiopulmonary bypass and are monitored for immediate post-operative outcomes

4 days

Daily monitoring post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in gut microbiome and inflammatory markers

4 months

Treatment Details

Interventions

• Butyric Acid

Trial Overview The study tests if butyric acid supplements can improve gut health in these young patients. It will compare two doses of SunButyrate-TG against a placebo to see how they affect the gut microbiome, metabolism, genetic markers of intestinal function, and inflammation after heart surgery.

Participant Groups

Group I: 4 mL SunButyrate-TG (Arm 2) Experimental Treatment 1 Intervention

Participants will receive 4 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.

Group II: 2 mL SunButyrate-TG (Arm1) Experimental Treatment 1 Intervention

Participants will receive 2 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.

Group III: Placebo Comparator (Arm 3) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The Effects of Butyric Acid on the Differentiation, Proliferation, Apoptosis, and Autophagy of IPEC-J2 Cells. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Rationale for the luminal provision of butyrate in intestinal diseases. [2019]

3. Poland pubmed.ncbi.nlm.nih.gov

Determination of butyric acid dosage based on clinical and experimental studies - a literature review. [2020]

4. Greece pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Apoptotic Induction of Butyric Acid Derivatives in Colorectal Carcinoma Cells. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Supplementation of enteral nutrition with butyrate leads to increased portal efflux of amino acids in growing pigs with short bowel syndrome. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of different protections of butyric acid aiming for release in the last part of the gastrointestinal tract of piglets. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Short chain fatty acid-induced colitis in mice. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

Butyric acid, a gut bacteria metabolite, lowers arterial blood pressure via colon-vagus nerve signaling and GPR41/43 receptors. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Dietary Supplementation with Clostridium butyricum on Growth Performance, Serum Immunity, Intestinal Morphology, and Microbiota as an Antibiotic Alternative in Weaned Piglets. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Butyric acid is synthesized by piglets. [2018]