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

Summary

Poor body weight gain and failure to thrive is a very common condition in patients with congenital heart disease (CHD) with advanced HF and/or cyanosis, which are considered a predictor of morbidity and complicate the prognosis of CHD. Studies have been carried out an attempt to discover the mechanisms to improve the therapies and the prognosis of these patients. Some of these studies give the hypothesis that the gastrointestinal tract, more precisely the intestine, can collaborate with metabolome. Extra-intracardiac shunt and HF lead to hypoperfusion and cyanotic heart disease leads to hypoxia. These two conditions make the gastrointestinal tract of these patients to become more mal-absorption to food. Consequently, the poor intestinal microcirculation and resultant dysbiosis may contribute to poor body weight gain and the worsening of prognosis. As known, probiotics can help to maintain or recover the microbiota and maintain a healthy intestinal barrier. In view of the importance of microbiota to the metabolism and the possible beneficial effect in the prognosis of heart-failure patients and the performance of microbiota in maintenance of intestinal barrier, this study has as primary objective to verify the influence of supplementation of the probiotic Lactobacillus Rhamnosus in the patients with CHD.

Malabsorption and dysbiosis in patients with CHD Poor body weight gain and failure to thrive is a very common condition in patients with congenital heart disease (CHD). Dysbiosis occurs in patients with CHD. Such dysbiosis and intestinal barrier dysfunction may become worsen after they underwent cardiopulmonary bypass, and complicate the prognosis of CHD.

Probiotics and Metabolome in Heart failure Cumulative evidence shows increasing importance of microbiota and cardiovascular disease and health. Metabolomic changes are found in CHD patients with hypoxia. It is suggested that Lactobacillus strains function to promote cardiovascular-related conditions. However, the effect of probiotic administration on CHD remains controversial. The investigators propose that hypothesis that Lactobacillus Rhamnosus directly improve the body weight gain and indirectly improve the outcome of patients with CHD. Accordingly, the investigators initiate this clinical trial to testify the beneficial effect of Lactobacillus Rhamnosus on CHD.

Conditions

• Congenital Heart Disease
• Dysbiosis
• Malnutrition, Child
• Probiotics
• Metabolome

Interventions

DRUG

Lactobacillus Rhamnosus

Lactobacillus Rhamnosus (Lactobacillus Rhamnosus, MoProbi-LR Capsules, Drug permit license 052531); Age \< 2 years old: 1/2 capsule once daily for 24 weeks per oral Age ≥ 2 years old: 1 capsule once daily for 24 weeks per oral

DRUG

Placebo

Maltodextrin comparable in color. Age \< 2 years old: 1/2 capsule once daily for 24 weeks per oral Age ≥ 2 years old: 1 capsule once daily for 24 weeks per oral

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-28

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Taiwan

Study Locations