Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life

CD Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hepatic Encephalopathy; Chronic Liver Disease

Treatments: Drug: VSL#3; Drug: Lactulose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01008293

MHE-VSL3-YKJ_AIIMS_ver1

Details and patient eligibility

About

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.

Full description

The study design would comprise of two parts

1. Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD

   1. 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.
   2. Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
   3. The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
   4. The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes

2. 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.

   1. All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
   2. All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
   3. 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.

Enrollment: 120 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

VSL#3

Experimental group

Treatment:

Drug: VSL#3

Lactulose

Active Comparator group

Description:

30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools

Treatment:

Drug: Lactulose