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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT06495333
Eligibility Criteria:
Inclusion Criteria:
A subject must meet the following criteria to be eligible for inclusion in the study:
Patient must be of Hispanic ethnicity residing in Puerto Rico. Age 21 to 75 years old at time of informed consent. Evidence of MASLD by vibration-controlled transient elastography (FibroScan) controlled attenuation parameter (CAP) (value must be greater than or equal to 248 dB/m).
Willing and able to provide informed consent signed by study subject. Willing and able to understand and complete study-related procedures.
Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from the study:
Excessive alcohol intake for ≥3 months during past year prior to screening (\>3 units/day for males and \>2 units/day for female is generally considered excessive).
History of liver transplant, or current placement on a liver transplant list. History of viral and resolved hepatitis (Hepatitis B or C) or human immunodeficiency virus (HIV).
Use of antibiotics within 14 days of screening.
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT06495333
Study Brief:
Protocol Section:
NCT06495333