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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT00914056
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hepatic cirrhosis based on biopsy, clinical and/or radiological findings.
* Stable HE (chronic): On daily lactulose for more than 6 months without hospitalization for HE within 3 months of enrollment.
* Treated with lactulose on a daily basis, with restoration of mental status to baseline.
* Lives with an adult individual who is willing to serve as a full-time caregiver.
* Able and willing to give informed consent.
Exclusion Criteria:
* Use of antibiotics, including rifaximin.
* Patient without an adult caregiver.
* Pre-existing focal neurological deficits, seizures or other indication of structural neurological disorder.
* Actively abusing illicit drugs or alcohol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00914056
Study Brief:
Protocol Section:
NCT00914056