Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 2

Conditions: Hepatic Encephalopathy; Cirrhosis

Treatments: Drug: Comparison between Lactulose and Lactulose-Paraffin

Study type: Interventional

Funder types: Other

Identifiers

NCT02017119

GAS-282-10/11-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Lactulose

Experimental group

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).

Treatment:

Drug: Comparison between Lactulose and Lactulose-Paraffin

Lactulose-paraffin

Experimental group

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).

Treatment:

Drug: Comparison between Lactulose and Lactulose-Paraffin