Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients: Impact on the Recurrence of Encephalopathy, Tolerance and Adherence to Treatment, Costs, and Quality of Life

Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively low, due to side effects such as diarrhea, distention, etc.

Study Overview

• Status: Completed
• Conditions: Hepatic Encephalopathy; Cirrhosis
• Intervention / Treatment: Drug: Comparison between Lactulose and Lactulose-Paraffin

Detailed Description

Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively low due to side effects. Lactulose-paraffin recently available in the market can be used for the treatment of HE, and possibly have fewer side effects.

The aim of this study was to compare the adherence of the treatment of lactulose and lactulose-paraffin.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14000
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Liver cirrhosis
• History of an event of hepatic encephalopathy.
• Ambulatory patients

Exclusion Criteria:

• Alcoholism with active ingest of alcohol in the last 6 months
• Labour turn-overs
• Pregnancy
• Personal history of surgery in the last 4 weeks
• Spontaneous bacterial Peritonitis
• Use of neuropsychiatric drugs
• Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
• Thyroid disorders without replacement therapy
• Renal failure
• Hepatic or renal transplant
• Personal history of hepatocellular carcinoma
• Placement of transjugular intrahepatic portosystemic shunt
• Use of a probiotic in the last 6 month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lactulose; Lactulose 15ml oral intake 8hrs daily for 6 months. The dose may be modified depending on the number of total bowel movements, (the expected range is 2 - 4 per day).	Drug: Comparison between Lactulose and Lactulose-Paraffin
EXPERIMENTAL: Lactulose-paraffin; Paraffin 15g daily for 6 months. The dose may be modified depending on the number of total bowel movements, (the expected range is 2 - 4 per day).	Drug: Comparison between Lactulose and Lactulose-Paraffin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to treatment	Provide evidence of better adherence to treatment with lactulose-paraffin in cirrhotic patients with a history of hepatic encephalopathy, which should be reflected in fewer hospitalizations, lower costs and better quality life.	6 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (ESTIMATE): December 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: GAS-282-10/11-1