Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids (BASICS-Kids)

University of Nebraska

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Congenital Heart Disease (CHD)

Treatments: Drug: 4 mL SunButyrate-TG; Drug: Placebo; Drug: 2 mL SunButyrate-TG

Study type: Interventional

Funder types: Other

Identifiers

NCT06882772

0839-24-FB

11543 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 1 month to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups, including a placebo group

2 mL SunButyrate-TG (Arm1)

Experimental group

Description:

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

Treatment:

Drug: 2 mL SunButyrate-TG

4 mL SunButyrate-TG (Arm 2)

Experimental group

Description:

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

Treatment:

Drug: 4 mL SunButyrate-TG

Placebo Comparator (Arm 3)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo