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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02017119

Enrollment

Registered

2013-12-20

Start date

2011-01-31

Completion date

2014-06-30

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hepatic Encephalopathy

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.

Interventions

DRUGComparison between Lactulose and Lactulose-Paraffin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026