Back to resultsComparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients
Primary Purpose
Cirrhosis, Hepatic Encephalopathy
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Comparison between Lactulose and Lactulose-Paraffin
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
Eligibility Criteria
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
Sites / Locations
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lactulose
Lactulose-paraffin
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02017119
First Posted
December 16, 2013
Last Updated
August 18, 2014
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT02017119
Brief Title
Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Hepatic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactulose
Arm Type
Experimental
Arm Description
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).
Arm Title
Lactulose-paraffin
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Comparison between Lactulose and Lactulose-Paraffin
Primary Outcome Measure Information:
Title
Adherence to treatment
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients
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