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โ† Trials
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Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

RecruitingPhase 1, Phase 2Ages 1 Month - 3 YearsAllUniversity of Nebraska
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Infants and Children undergoing cardiac surgery with cardiopulmonary bypass Exclusion Criteria: * 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
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What it tests

  • 2 mL SunButyrate-TG
  • Placebo
  • 4 mL SunButyrate-TG
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Where

1 site
Children's Nebraska, 8200 Dodge St
Omaha, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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