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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT03985020
Eligibility Criteria:
Inclusion Criteria:
* Age: 10-18 years
* ALT \> 45 IU/L (twice the normal amount)
* BMI \>85%
* Fat \>5% and kPa\> 2.7
Exclusion Criteria:
* Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity.
* Familial hyperlipidemia
* Positive hepatitis lab
* Antibiotics within 1 month of beginning the study
* Physical, mental, or cognitive issues preventing participation
* Pregnancy
* Smoking or drinking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT03985020
Study Brief:
Protocol Section:
NCT03985020