The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease

Launched by CHANG GUNG MEMORIAL HOSPITAL · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a probiotic called Lactobacillus Rhamnosus on children with congenital heart disease (CHD) who are experiencing heart failure. Many of these children struggle with gaining weight and often have issues with their gut health, which can make their overall condition worse. The researchers believe that by giving these children probiotics, they may help improve their gut health and, in turn, support better weight gain and overall health.

To participate in this study, children must be 3 years old or younger and have specific types of heart disease with some degree of heart failure. They should not have been hospitalized for heart failure in the past month and must have a signed consent form from their parents or guardians. Participants in the trial will receive the probiotic treatment and will be monitored to see if it helps with their weight gain and health outcomes. This trial aims to provide valuable information on how probiotics might benefit young patients with heart conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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;
• • 2. No recent 1-month hospitalizations for HF decompensated;
• • 3. Have signed the Free and Informed Consent Form.
• Exclusion Criteria:
• • 1. CHD with NYHA functional class IV or ejection fraction \< 35%;
• • 2. Do not accept to participate in the study or do not sign the Free and Informed Consent Form;
• • 3. Have used antibiotics and/or corticosteroids and/or other formula containing probiotics in the last 30 days prior enrollment;
• • 4. Clinical conditions that can affect the inflammatory profile such as inflammatory bowel disease, arthrosis, among others;
• • 5. Chronic severe diarrhea (\> 2 weeks; \> 5 times/day) in the last 3 months;
• • 6. Have been submitted to a cardiac surgery or other surgery in the last 3 months;
• • 7. Severe lactose intolerance;
• • 8. Profound anemia (WBC\> 15000, Hb\< 8 ) or hematologic disorder, severe hepatic dysfunction (GPT\> 100), renal function (Cr\> 1.5), abnormal stool analysis or active infection status (CRP\> 10).