Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic liver disease of whichever etiology
- •Minimal hepatic encephalopathy
- •Lactose maldigestion
排除标准
- •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
结局指标
主要结局
Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
时间窗: 30 days after intervention
Improve in Psychometric Hepatic Encephalopathy Score (PHES). The PHES includes five psychometric test: number connectiontests A and B; the digit symbol test; the line tracing test and the serial dotting test. To calculate th PHES, the validated equations for Mexican population will be used. Patients will be diagnosed with MHE when the PHES will be less than -4 points.
次要结局
- Quality of life in patients with cirrhosis and minimal hepatic encephalopathy(30 days after intervention)
研究者
Segundo Moran Villota
Asociado B
Coordinación de Investigación en Salud, Mexico