Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT06872320
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
3 Years
Study:
NCT06872320
Study Brief:
Protocol Section:
NCT06872320