A Study of Controlled Lactulose Withdrawal

Status Completed

Clinical Trial 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.

Clinical Trial 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 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 We hypothesize that a majority of these patients can be withdrawn from daily lactulose therapy without deterioration of cognitive function, and that lactulose withdrawal will improve symptoms and quality of life for these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. ;

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00914056
Study type	Interventional
Source	Hunter Holmes Mcguire Veteran Affairs Medical Center
Contact
Status	Completed
Phase	N/A
Start date	September 2008
Completion date	May 2012

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT01846806` - The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.	N/A
Completed	`NCT01559519` - Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy	Phase 4
Recruiting	`NCT01178372` - Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis	Phase 4
Completed	`NCT00740142` - Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy	Phase 4
Completed	`NCT00558038` - Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy	Phase 2
Completed	`NCT00986895` - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group	Phase 1
Completed	`NCT00287235` - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)	N/A
Recruiting	`NCT05539027` - Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy	Phase 4
Recruiting	`NCT04096014` - Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy	N/A
Completed	`NCT05526404` - Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration	N/A
Completed	`NCT04082780` - Rifamycin in Minimal Hepatic Encephalopathy	Phase 2
Enrolling by invitation	`NCT06367127` - Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Active, not recruiting	`NCT05425316` - Speech in Hepatic Encephalopathy (HE)
Recruiting	`NCT04415294` - Flicker App for Minimal Hepatic Encephalopathy
Not yet recruiting	`NCT06072521` - Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy	Phase 2
Withdrawn	`NCT02086825` - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure	Phase 3
Completed	`NCT02636647` - Fecal Transplant in Recurrent Hepatic Encephalopathy	Phase 1
Completed	`NCT01446523` - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE	N/A
Completed	`NCT01218568` - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial	N/A
Completed	`NCT01008293` - Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life	Phase 2/Phase 3