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:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT03261466
Eligibility Criteria:
Inclusion Criteria:
1. both sexes
2. between 6 and 18 years of age
3. obese, according to the IOTF criteria (Cole TJ et al., 2000)
4. pubertal stage ≥ 2 according to the Tanner stage (Tanner et al., 1961)
5. HOMA-IR \> 2,5 or insulin \> 15 µU/ml
Exclusion Criteria:
1. Adverse reactions to the product or component of the product (allergies…)
2. Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-biedl syndrome…), endocrinological obesity (Cushinch syndrome, hypotiroidism)
3. Chronic diseases, hepatic or gastroenterological diseases
4. Medical treatment for chronic diseases
5. Probiotic or prebiotic therapies and antibiotic treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT03261466
Study Brief:
Protocol Section:
NCT03261466