Suspended

Probiotics for Heart Failure in Children with Congenital Heart Disease

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What is being tested

Lactobacillus Rhamnosus

+ Placebo

Drug
Who is being recruted

Congenital Abnormalities+9

+ Cardiovascular Diseases

+ Heart Defects, Congenital

From 1 Months to 3 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorChang Gung Memorial Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring the impact of probiotics on children with congenital heart disease (CHD) who have heart failure. The study involves children under three years old with certain heart conditions, and it aims to see how probiotics can affect their heart rate variability and overall metabolic health. Heart rate variability is a measure of how the heart adjusts its speed, which can indicate how well the heart is functioning. The research hopes to discover if probiotics can improve the health outcomes for these children, potentially offering a new treatment approach for managing heart failure in young patients. Participants in the study will be randomly divided into two groups, with one group receiving a daily probiotic supplement and the other receiving a placebo. The study lasts for 24 weeks, during which participants will take their assigned supplement by mouth. Researchers will collect blood samples at the start, middle, and end of the study to measure various health markers. They will also evaluate heart function through echocardiograms and monitor the children's growth and dietary intake. The primary goal is to see if the children taking probiotics experience better health outcomes, such as improved heart function and growth, compared to those taking the placebo.

Official TitleThe Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease
NCT06872320
Principal SponsorChang Gung Memorial Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Congenital AbnormalitiesCardiovascular DiseasesHeart Defects, CongenitalHeart DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsChild Nutrition DisordersCardiovascular AbnormalitiesDysbiosis

Criteria

3 inclusion criteria required to participate
Patients at ages ≤ 3 years old with congenital structure/valvular heart disease and cardiomyopathy with varying degrees of HF NYHA/ROSS functional class and ejection fraction ≥ 35% by echocardiography at the entry of study;
No recent 1-month hospitalizations for HF decompensated;
Have signed the Free and Informed Consent Form.
8 exclusion criteria prevent from participating
CHD with NYHA functional class IV or ejection fraction < 35%;
Do not accept to participate in the study or do not sign the Free and Informed Consent Form;
Have used antibiotics and/or corticosteroids and/or other formula containing probiotics in the last 30 days prior enrollment;
Clinical conditions that can affect the inflammatory profile such as inflammatory bowel disease, arthrosis, among others;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Maltodextrin, Magnesium Stearate

Group II

Active Comparator
Lactobacillus Rhamnosus (More than 1 billion colonies), Maltodextrin, Magnesium Stearate

Study 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

Suspended

Kaohsiung Chang Gung Memorial Hospital and Chang Gung University

Kaohsiung City, TaiwanOpen Kaohsiung Chang Gung Memorial Hospital and Chang Gung University in Google Maps
SuspendedOne Study Center