Clinical trial NCT01008293: Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Liver Disease
Hepatic Encephalopathy
Lead sponsor: CD Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Indian Council of Medical Research
name: All India Institute of Medical Sciences
First posted: 2009-11-05
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Dept. of Gastroenterology and H.N.U., All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Y K Joshi, Prof.
role: PRINCIPAL_INVESTIGATOR
References: