A Study of Controlled Lactulose Withdrawal

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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 never been shown in randomized, controlled trials to be effective for preventing exacerbations of HE. Indeed, lactulose was found to be ineffective at preventing HE when administered prophylactically to patients undergoing portosystemic shunt insertion. While some patients may be lactulose dependent following an initial episode of HE, it is likely that most could have their lactulose discontinued with no adverse consequences.

This goal is worth pursuing because lactulose is not innocuous. It has an unpleasant taste, and it routinely produces gastrointestinal symptoms, including bloating, gas and diarrhea. In high doses it can cause incontinence, dehydration and electrolyte derangements. Patients universally dislike taking lactulose and often are noncompliant with treatment. A recent trial showed that patients on lactulose had a substantial risk of hospital admissions due to lactulose-related complications and treatment non-compliance.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Treatments: Lactulose

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.