Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 5:28 AM
Study NCT ID:
NCT01008293
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2009-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
Sponsor:
CD Pharma India Pvt. Ltd.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MHE
Brief Summary:
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.
* 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: