Butyric Acid for Gut Improvement After Heart Surgery in Kids
(BASICS-Kids Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how butyric acid, a compound known to support gut health, can aid infants and young children with congenital heart disease (CHD) who require heart surgery. Researchers aim to determine if butyric acid is safe and can enhance gut health and reduce inflammation post-surgery. Participants will receive either a daily dose of butyric acid or a placebo (inactive substance) for three weeks before their surgery. This trial suits infants and children needing heart surgery involving a heart-lung machine, provided they haven't had recent antibiotics, surgery, or certain ongoing health issues. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.
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.
Is there any evidence suggesting that butyric acid is likely to be safe for infants and young children with congenital heart disease?
Research has shown that butyric acid has been safely used in older children with inflammatory bowel disease. However, there is not enough information yet to determine its safety for infants and young children, particularly those with congenital heart problems. This study is in its initial stages. The primary goal is to assess the safety and tolerability of butyric acid for young children. Early studies like this one help identify any side effects and evaluate how well children respond to the treatment.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about using butyric acid for gut improvement after heart surgery in kids because it introduces a new approach to managing gut health. Unlike traditional treatments that often focus on symptoms or use medications targeting inflammation, butyric acid works by directly nourishing the gut lining and promoting beneficial bacteria. This unique mechanism could lead to faster recovery and improved overall gut function, making it a promising addition to current care strategies. Plus, the use of SunButyrate-TG, with its specific dosing options, offers flexibility in tailoring the treatment to individual needs.
What evidence suggests that butyric acid might be an effective treatment for gut improvement after heart surgery in children?
Research has shown that butyric acid supports gut health by maintaining a healthy balance of good bacteria. This effect has been observed in adults and older children, particularly those with inflammatory bowel disease. Gut bacteria produce butyric acid, which helps reduce inflammation. Studies have also linked it to better recovery after heart problems in adults. Although its effects on infants and young children with congenital heart disease are not fully understood, its known benefits for gut health and reducing inflammation suggest potential usefulness. In this trial, participants will receive either 2 mL or 4 mL of SunButyrate-TG, or a placebo, to evaluate its potential to lower inflammation in children undergoing heart surgery. Early findings suggest it might help reduce inflammation in these children.12367
Who Is on the Research Team?
Jeffrey Salomon, MD, MBA
Principal Investigator
University of Nebraska
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Supplementation
Participants receive butyric acid or placebo supplementation once daily for 3 weeks prior to cardiac surgery
Surgery and Immediate Post-operative Monitoring
Participants undergo cardiac surgery with cardiopulmonary bypass and are monitored for immediate post-operative outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in gut microbiome and inflammatory markers
What Are the Treatments Tested in This Trial?
Interventions
- Butyric Acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor