Status:
COMPLETED
A Study of Controlled Lactulose Withdrawal
Lead Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is routinely continued indefinitely as maintenance therapy. Although widely used for this indication, lactulose has ne...
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00914056
Start Date
September 1 2008
End Date
May 1 2012
Last Update
March 20 2013
Active Locations (1)
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1
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249