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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT04620057
Eligibility Criteria:
Inclusion Criteria:
* Children/adolescents with diagnosis of obesity (BMI \>95° percentile for age and sex) observed at Pediatric Section of Department of Translational Medical Sciences (University of Naples Federico II)
Exclusion Criteria
* Age at enrollment \<5 or \>17 years
* BMI \<95° percentile for age and sex
* Patients under pharmacological treatment for obesity (metformin)
* Patients assuming vitamin E,
* Patients assuming pre-, pro- or synbiotics
* Simultaneous presence of other chronic diseases unrelated to obesity:
* cancer,
* immunodeficiency,
* cystic fibrosis,
* allergies,
* celiac disease,
* autoimmune diseases,
* neuropsychiatric disorders,
* type 1 diabetes,
* inflammatory bowel diseases,
* malformations of urinary or gastrointestinal or respiratory tract,
* chronic lung diseases, genetic and metabolic diseases,
* chronic hematological diseases.
* History of surgery for the treatment of obesity
* Any medical condition that may interfere with participation in this study
* Participation in other clinical trials still in progress
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT04620057
Study Brief:
Protocol Section:
NCT04620057