Health Related Quality of Life in Patient With Chronic Liver Disease and Effect of Probiotics in the Treatment of MHE and Health Related Quality of Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL
研究概览
简要总结
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below:
- To study the health related quality of life (HRQOL) in patients with chronic liver disease.
- To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with chronic liver disease and assessment of HRQOL in patients with MHE.
- To compare the effect of probiotics and lactulose in the treatment of MHE
- To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.
详细描述
The study design would comprise of two parts
-
Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD
-
All the consecutive patients diagnosed as CLD would be enrolled in the study. All these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at AIIMS.
-
Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
-
The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
-
The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes
-
Part II: Prospective randomized controlled trial: In this part the outcome of lactulose and probiotic therapy in the treatment of MHE and its effect on the HRQOL will be compared.
-
All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
-
All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
-
The diagnosis of MHE would be based on abnormal psychometric tests (NCT-A and NCT-B or FCT-A and FCT-B) and /or abnormal P300 auditory event related potentials.
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
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients with Chronic Liver Disease or Minimal Hepatic Encephalopathy (without overt hepatic encephalopathy) aged between 15 to 80 years of both the genders would be enrolled consecutively.
排除标准
- •Patients with overt hepatic encephalopathy
- •Active medical co-morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
- •Malignancy
- •History of taking lactulose or probiotics or antibiotics, in the past 6 weeks
- •Presence of other neurological or psychiatric disorder
- •Patients who underwent shunt surgery for portal hypertension
- •History of taking medicines likely to interfere with psychometric performance
- •History of GI hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks
- •Presence of mature cataracts and diabetic retinopathy
- •Refused to participate in the study
研究组 & 干预措施
VSL#3
干预措施: VSL#3 (Drug)
Lactulose
30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools
干预措施: Lactulose (Drug)
结局指标
主要结局
To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL
时间窗: 2 months
次要结局
未报告次要终点