Probiotics in childhood viral encephalitis
- Conditions
- Health Condition 1: null- Admitted with a diagnosis of viral encephalitis
- Registration Number
- CTRI/2011/11/002127
- Lead Sponsor
- India Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 380
Diagnosed with acute encephalitis: Clinical definition : Any person, of any age, admitted to hospital with encephalopathy (altered level of consciousness persisting for >24 h and including lethargy, irritability or a change in personality and behaviour) and >= 2 of the following :
1. Fever or history of fever (>=380 C) ;
2. seizures and/or focal neurological findings (with evidences of brain parenchymal involvement ) ;
3. CSF pleocytosis ( > 4 WBC/ ml) ;
4. Electroencephalogram findings compatible with encephalitis ;
5. Abnormal results of neuroimaging in keeping with encephalitis.
Patients having risk factor of small intestinal bacterial overgrowth other than cirrhosis - diabetes mellitus, history of abdominal surgery, immunomodulator drugs.
Patients with active gastrointestinal bleed, intestinal obstruction or peritonitis or any other reason to withhold oral drug administration.
Patients with advanced hepatocellular failure, renal failure and portal vein thrombosis
Patients with suspected or proven rabies
Diagnosed HIV positive or any other condition causing immune-deficiency
Children with proven or suspected malignancies
Evaluation and laboratory testing
o Detailed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportions of patients with a favorable outcome (pediatric cerebral performance category scale of 1-3) in each group at 3 months after dischargeTimepoint: 3 months after discharge
- Secondary Outcome Measures
Name Time Method Mortality in each group during hospital stay <br/ ><br>Adverse effects of therapy in both the groups <br/ ><br>Etiology of encephalitis in the whole population of enrolled patientsTimepoint: at discharge