BASICS-KidsButyric Acid for Gut Health in Children Undergoing Cardiac Surgery
2 mL SunButyrate-TG
+ Placebo
+ 4 mL SunButyrate-TG
Congenital Abnormalities+6
+ Cardiovascular Diseases
+ Heart Defects, Congenital
Other Study
Summary
Study start date: June 1, 2025
Actual date on which the first participant was enrolled.The study explores the use of butyric acid in a liquid form to help improve gut health in infants and young children, aged 1 month to 3 years, who have congenital heart disease and are scheduled for cardiac surgery. The aim is to see if taking this supplement daily for three weeks before surgery can make the gut healthier, potentially reducing issues like gut permeability and inflammation after the surgery. This is important because reducing these complications could lead to better recovery and outcomes for children undergoing heart surgery. In the study, participants will be assigned to one of three groups: one taking 2 mL of butyric acid, another taking 4 mL, and a third taking a placebo, all once a day for three weeks before their surgery. They will provide blood and stool samples at various times to check for changes in their gut health and inflammation levels. Participants will also keep a daily log to record when they take the supplement and any side effects. The study will measure the supplement's safety and its effects on gut health and inflammation by analyzing these samples and logs.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.105 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 Months to 3 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Children's Nebraska, 8200 Dodge St
Omaha, United StatesOpen Children's Nebraska, 8200 Dodge St in Google Maps