Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017119
• Other study ID #: GAS-282-10/11-1
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2013
• Last updated: August 18, 2014
• Start date: January 2011
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Hepatic Encephalopathy

Intervention

Drug:
• Comparison between Lactulose and Lactulose-Paraffin

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No