Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Phase 2CompletedNCT02017119

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran40 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cirrhosis Hepatic Encephalopathy

Interventions

Comparison between Lactulose and Lactulose-ParaffinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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