Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Overall Status

Completed

CT.gov ID

NCT02017119

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Hepatic Encephalopathy	Drug: Comparison between Lactulose and Lactulose-Paraffin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: Comparison between Lactulose and Lactulose-Paraffin
Experimental: 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).	Drug: Comparison between Lactulose and Lactulose-Paraffin

Arm

Intervention/Treatment

Experimental: 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).

Drug: Comparison between Lactulose and Lactulose-Paraffin

Experimental: 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).

Drug: Comparison between Lactulose and Lactulose-Paraffin

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City		Mexico	14000

Sponsors and Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ALDO TORRE DELGADILLO, Principal Investigator., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

ClinicalTrials.gov Identifier:

NCT02017119

Other Study ID Numbers:

GAS-282-10/11-1

First Posted:

Dec 20, 2013

Last Update Posted:

Aug 20, 2014

Last Verified:

Aug 1, 2014

Additional relevant MeSH terms:

Hepatic Encephalopathy

Brain Diseases

Lactulose

Study Results

No Results Posted as of Aug 20, 2014