NCT06872320

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

Active, enrolled NA Last updated 22 July 2025

What this trial tests

NA trial testing Lactobacillus Rhamnosus in Congenital Heart Disease in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 March 2025

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	28 March 2025
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Taiwan

Drugs / interventions tested

• Lactobacillus Rhamnosus — full drug profile →
• Placebo

Conditions studied

• Congenital Heart Disease — all drugs for Congenital Heart Disease →
• Dysbiosis — all drugs for Dysbiosis →
• Malnutrition, Child — all drugs for Malnutrition, Child →
• Probiotics — all drugs for Probiotics →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 1 Month to 3, any sex, with Congenital Heart Disease or Dysbiosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.