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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06539494
Eligibility Criteria:
Inclusion Criteria:
In case of the healthy subject group:
* Adult individuals, age \> 18 \<65 years
* Male or postmenopauzal females
* BMI \<25
* Ability to give informed consent In case of the MASLD/MASH group
* Adult individuals, age \> 18 \<65 years
* Male or postmenopauzal females
* BMI \> 25
* Biopsy proven MASLD/MASH
* Ability to give informed consent
Exclusion Criteria:
* History of sustained excess alcohol ingestion: daily consumption \>30g/day (3 drinks per day) for males and \>20 g/day (2 drinks per day) for females
* Patients with diabetes
* Bariatric surgery
* Other forms of liver disease (e.g. Hepatitis B,C, Wilson disease, hemochromatosis)
* Proton-pump inhibitor usage one year prior to study participation
* GLP1, SGLT2i or insulin use
* Antibiotic use for the past 3 months
* Probiotic or symbiotic usage
* Pregnant women
* Chronic illness (including a known history of heart failure, renal failure (eGFR \<30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
* Active infection
* Use of ascal, clopidogrel or other platelet inhibition
* Smoking
* Blood thinners
* Heart failure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06539494
Study Brief:
Protocol Section:
NCT06539494