Trial | NCT01008293  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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.
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.
Study Started
Oct 31
2009
Primary Completion
Jun 30
2012
Study Completion
Oct 31
2012
Last Update
Jun 04
2013
Estimate

Drug VSL#3

VSL#3 (2 capsules bid.for 2 months, Each containing 112.5 billion viable lyophilized bacteria). Each capsule contains 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus)

Drug Lactulose

30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.

  • Other names: Duphalac

VSL#3 Experimental

Lactulose Active Comparator

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

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
No Results Posted