Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids

NCT ID: NCT06882772

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Congenital Heart Disease (CHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

2 mL SunButyrate-TG (Arm1)

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

Group Type: EXPERIMENTAL

2 mL SunButyrate-TG

Intervention Type: DRUG

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.

4 mL SunButyrate-TG (Arm 2)

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

Group Type: EXPERIMENTAL

4 mL SunButyrate-TG

Intervention Type: DRUG

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.

Placebo Comparator (Arm 3)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery

Interventions

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.

Intervention Type: DRUG

Placebo

Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Butyrate Liquid Supplement; sugar pill; Butyrate Liquid Supplement

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Salomon, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Children's Nebraska, 8200 Dodge St

Omaha, Nebraska, United States

Countries

United States

Central Contacts

Jeffrey D Salomon, MD, MBA

Role: CONTACT

jeffrey.salomon@unmc.edu

940-453-7166

Facility Contacts

Jeffrey D Salomon, MD

Role: primary

jeffrey.salomon@unmc.edu

402-955-4264

Other Identifiers

11543

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0839-24-FB

Identifier Type: -

Identifier Source: org_study_id