Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy

Coordinación de Investigación en Salud, Mexico

Status: Terminated

Conditions: Hepatic Encephalopathy; Liver Cirrhosis

Treatments: Dietary Supplement: Lactose-free milk; Dietary Supplement: Whole milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01113567

2010-785-016

Details and patient eligibility

About

Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days. An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.

Full description

Mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. One of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (MHE), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. There are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. The administration of non-absorbable disaccharides has been proven to ameliorate MHE. Lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of MHE.

The aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic liver disease of whichever etiology
• Minimal hepatic encephalopathy
• Lactose maldigestion

Exclusion criteria

• Patients with clinical manifestations of hepatic encephalopathy
• Recent use of antibiotics or psychotropic drugs
• Recent use of alcohol abuse
• Gastrointestinal bleeding
• Others neurological disorders that affect the psychometric test
• Chronic renal failure
• Congestive heart failure
• Chronic Obstructive Pulmonary Disease
• Severe symptoms of lactose intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

18 participants in 2 patient groups, including a placebo group

Diet and lactose-free milk

Placebo Comparator group

Description:

Lactose-free milk

Treatment:

Dietary Supplement: Lactose-free milk

Diet and whole milk

Active Comparator group

Description:

Whole milk with lactose

Treatment:

Dietary Supplement: Whole milk