Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-06-30

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.

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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.

Conditions

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Cirrhosis Hepatic Encephalopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Comparison between Lactulose and Lactulose-Paraffin

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Comparison between Lactulose and Lactulose-Paraffin

Intervention Type DRUG

Interventions

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Comparison between Lactulose and Lactulose-Paraffin

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No