Probiotic preparation, VSL#3 as a support pharmaceutical therapy in cirrhotic patients for the treatment of minimal hepatic encephalopathy (MHE)
- Conditions
- Health Condition 1: null- Cirrhotic patients with Minimal Hepatic encephalopathy
- Registration Number
- CTRI/2008/091/000268
- Lead Sponsor
- CD Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and female patients aged more than 16 years;
2.Diagnosis of cirrhosis based on standard clinical and biochemical criteria and, possibly, biopsy proven;
3.No long-term antibiotic treatment needed
4.Able to provide written informed consent
1.Alcohol consumption or substance abuse within the last 3 months
2.Overt HE or a history of overt HE
3.Renal insufficiency with creatinine greater than 1.5 mg/dL (233 μmol/L)
4.Ongoing treatment for HE, including treatment with antibiotics (possible treatments should have been stopped at least one month before)
5.Need to take long term antibiotics for any reason
6.Pregnant females, or females planning to become pregnant, or nursing
7.Patients who are unable or unwilling to provide informed consent
8.Patients who are taking benzodiazepines, narcotics, anti-depressants, or anti-psychotic medication (previous medication with these drugs should have stopped by one month or more)
9.Patients with history of shunt surgery or transjugular intrahepatic portosystemic shunt (TIPSS) for portal hypertension
10.Patients with any other organic brain disease, including dementia from any cause, mental retardation, Wilson?s disease, previous stroke, TIA, etc.
11.Severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement;
12.Inability to perform NP tests due to bad vision
13.Patients with gastrointestinal dysfunction (motility, prior resection/surgery, obstruction)
14.Gastrointestinal bleeding within 30 days
15.Serious infection (e.g. peritonitis) within 30 days
16.Known hepatocellular carcinoma or AFP>400
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the evaluation of the beneficial effects of supplementation with VSL#3® in cirrhotic patients assessed by a reduction in MHE prevalence and improvement in cognitive functions assessed by psychometric hepatic encephalopathy score (PHES).Timepoint: 16 weeks
- Secondary Outcome Measures
Name Time Method Assessment of the beneficial effects of food supplementation with the probiotic preparation VSL#3® on:<br>?Improvement in health related quality of life (HR-QOL) (SF-36 score)<br>?Prevention of major complications of cirrhosis (overt encephalopathy, variceal bleeding, spontaneous bacterial peritonitis, and hepatopulmonary syndrome) <br>?Liver function <br>?Renal functions<br>?Improvement in hypoxia<br>?Blood ammonia levels, blood cytokines levels, <br>?Small intestinal bacterial overgrowth and orocecal transit time<br>?HVPG<br>?Hospital admissions due to cirrhosis complications<br>?Survival time after study medication<br>Timepoint: 16 weeks and 20 weeks