Effect of probiotics in the treatment of MHE and health related quality of life

Phase 2

Completed

• Conditions: Health Condition 1: null- Minimal Hepatic Encephalopathy (MHE) in patients with chronic liver disease

• Registration Number: CTRI/2010/091/000125
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

All the patients with Chronic liver disease (CLD) aged between 15 to 80 years of both the genders would be enrolled consecutively. Selection criteria would be the following:

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 more than or equal to 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:-

a.viral hepatitis

b.alcohol

c.viral hepatitis combining with alcohol

d.miscellaneous causes

Part II: All the patients of both genders with MHE aged between 15 to 80 years of both the genders would be enrolled consecutively. Selection criteria would be the following:

1.All the consecutive patients with CLD without overt encephalopathy would be screened for MHE and then recruited

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

Exclusion Criteria

Part I:
1. Patients with overt hepatic encephalopathy
2. Active medical co-morbidities
3. Malignancy
4. Refused to participate in the study

Part II:
1.Presence of overt HE
2.History of taking lactulose or probiotics or antibiotics, in the past 6 weeks.
3.Presence of other neurological or psychiatric disorder
4.Patients who underwent shunt surgery for portal hypertension
5.History of taking medicines likely to interfere with psychometric performance
6.History of alcohol intake during past 6 weeks
7.History of GI hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks
8.Presence of significant co morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
9.Presence of mature cataracts and diabetic retinopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To Study the Health Related Quality of Life (HRQoL) in patients with chronic liver disease<br>2. To assess the prevalence of MHE in patients with CLD and assessment of HRQoL in patients with MHE<br>3. To compare the effects of probiotics and Lactulose in the treatment of MHE<br>4. To assess the effects of probiotics and Lactulose on the HRQoLin patients with MHE<br><br>Response to Treatment: <br>The response to treatment would be assessed on the following points:<br>1.Normalization of the abnormal test parameters<br>a.Neuropsychometric tests<br>b.Neurophysiologic tests<br>c.P3ERP<br>d.EEG<br>2.Assessment of venous ammonia levels<br>3.Development of overt encephalopathy<br>4.Development of other complications<br>5.Improvement in the HRQOL<br>Timepoint: 2 months

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Nil