Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

NCT02017119 | Completed Phase 2 DMC

• 1 other identifier: GAS-282-10/11-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lactulose

EXPERIMENTAL

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

Lactulose-paraffin

EXPERIMENTAL

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

Interventions

Comparison between Lactulose and Lactulose-Paraffin DRUG

Lactulose; Lactulose-paraffin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis
• History of an event of hepatic encephalopathy.
• Ambulatory patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator.

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: January 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

ME (1)