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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT07150195
Eligibility Criteria:
Inclusion Criteria:
For the NHE (No Hepatic Encephalopathy) Group:
1. Aged between 18 and 85 years, inclusive.
2. Diagnosis of liver cirrhosis.
3. Normal blood ammonia level.
4. West-Haven Criteria grade 0 for Hepatic Encephalopathy.
5. Normal neurological signs.
6. Normal neuropsychological test results.
7. Willing to participate and provides written informed consent.
For the CHE (Covert Hepatic Encephalopathy) Group:
1. Aged between 18 and 85 years, inclusive.
2. Diagnosis of liver cirrhosis.
3. Elevated blood ammonia level.
4. Diagnosis of Covert Hepatic Encephalopathy (West-Haven Criteria grade 0 or I).
* Grade 0: No personality or behavioral changes but abnormal neuropsychological tests.
* Grade I: Mild cognitive impairment, lack of awareness, euphoria or anxiety, shortened attention span, or impaired performance of addition/subtraction.
5. Neurological signs are normal or mild asterixis (flapping tremor) may be elicited.
6. Neuropsychological tests are abnormal.
7. Willing to participate and provides written informed consent.
Exclusion Criteria:
1. Diagnosis of any malignant tumor.
2. History of treatment for any malignant tumor.
3. Presence of severe concomitant cardiac, pulmonary, cerebral, or renal diseases, or severe diabetic complications.
4. Use of antibiotics, prebiotics, probiotics, or proton pump inhibitors within the three months prior to enrollment.
5. Pregnancy, lactation, or puerperium.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07150195
Study Brief:
Protocol Section:
NCT07150195