NCT06872320Active, not recruiting
The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease
Source: ClinicalTrials.gov · Last updated 22 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 28 Nov 2024
- Start date
- 28 Mar 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Heart failure
- NCT number
- NCT06872320
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 28 Mar 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have used antibiotics and/or corticosteroids and/or other formula containing probiotics in the last 30 days prior enrollment;
Other illness
- Clinical conditions that can affect the inflammatory profile such as inflammatory bowel disease, arthrosis, among others;
- Have been submitted to a cardiac surgery or other surgery in the last 3 months;
Lab values
- CHD with NYHA functional class IV or ejection fraction \< 35%;
- 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).
Other
- Do not accept to participate in the study or do not sign the Free and Informed Consent Form;
- Chronic severe diarrhea (\> 2 weeks; \> 5 times/day) in the last 3 months;
- Severe lactose intolerance;
Who the study is looking for
- 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.
Age in the registry: 1 month to 3 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital and Chang Gung University Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.