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Not yet recruiting NCT06882772

Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

Phase I / Phase II Interventional Congenital Heart Disease (CHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2 mL SunButyrate-TG, Placebo, 4 mL SunButyrate-TG.
Who it may be relevant to
Registry conditions: Congenital Heart Disease (CHD). Basic parameters: 1 months — 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial

Overview

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.

Interventions

  • Drug 2 mL SunButyrate-TG
    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.
  • Drug Placebo
    Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery
  • Drug 4 mL SunButyrate-TG
    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.

Primary outcome measures

  • Combined Incidence of Adverse Events and Serious Adverse Events with Butyric Acid (SunButyrate-TG) Supplementation [Time frame: 3 years]
  • Tolerance of SunButyrate-TG [Time frame: Baseline to 3 weeks]
  • Changes to White Blood Cell Count with SunButyrate-TG Supplementation [Time frame: Baseline to 3 weeks]
  • Changes to Hematocrit with SunButyrate-TG [Time frame: Baseline to 3 weeks]
  • Changes in Platelets with SunButyrate-TG [Time frame: Baseline to 3 weeks]
  • Changes to Renal Function (BUN, Creatinine or urine output) with SunButyrate-TG [Time frame: Baseline to 4 months]
  • Changes in Liver Function with SunButyrate-TG [Time frame: Baseline to 4 months]
  • 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 in Short-Chain Fatty Acids with SunButyrate-TG [Time frame: Baseline to 4 months]
  • Gut Barrier Function after SunButyrate-TG [Time frame: Baseline to 4 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Children's Nebraska, 8200 Dodge St — Omaha

Identifiers

NCT: NCT06882772 · 0839-24-FB · 11543

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗