Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Phase 2

Completed

• Conditions: Cirrhosis; Hepatic Encephalopathy
• Interventions: Drug: Comparison between Lactulose and Lactulose-Paraffin

• Registration Number: NCT02017119
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose	Comparison between Lactulose and Lactulose-Paraffin	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).
Lactulose-paraffin	Comparison between Lactulose and 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).

Primary Outcome Measures

Name	Time	Method
Adherence to treatment	6 months	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.

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Mexico