Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cirrhosis, Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Comparison between Lactulose and Lactulose-Paraffin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactulose<br>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<br> <br> |
| Experimental: Lactulose-paraffin<br>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<br> <br> |

What is the study measuring?
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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 |