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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT05061992
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of cirrhosis - must meet one of the following criteria:
1. liver biopsy, OR
2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
3. 2 of the following 4 criteria:
1. Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
2. Fibroscan liver stiffness score \>13 Kilopascal (kPa)
3. Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) \>2.0
4. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
Exclusion Criteria:
* Non-English speaking
* Pregnancy (self-reported)
* Unable or unwilling to provide consent
* History of liver transplant
* Disorientation at the time of enrollment, Dementia, or Treated Memory Disorder
* History of prior lactulose use or HE within 6 months
* Metastatic solid malignancy or blood malignancy
* Hemoglobin A1C \> 12 (within past year)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05061992
Study Brief:
Protocol Section:
NCT05061992