A Study of Controlled Lactulose Withdrawal

In this pilot study we propose to perform controlled lactulose withdrawal in selected patients with HE whose initial presentation follows a clearly defined, reversible precipitating event or those with stable, chronic HE. We hypothesize that a majority of these patients can be withdrawn from daily lactulose therapy without deterioration of cognitive function, and that lactulose withdrawal will improve symptoms and quality of life for these individuals. We propose to carry out a comprehensive battery of clinical, laboratory, microbiological and psychometric evaluations before and after lactulose withdrawal. We will closely follow changes in cognitive function and re-institute lactulose therapy at the first sign of clinical deterioration. Through multivariate analysis we propose to develop a model to discriminate between treatment dependent and treatment independent patients.

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.