CTRI/2011/11/002127
Not yet recruiting
Phase 3
Evaluation of safety and efficacy of adjuvant probiotics therapy in children with viral meningoencephalitis/ encephalitis: A randomized double blind controlled trial - PROVEC
India Council of Medical Research0 sites380 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Admitted with a diagnosis of viral encephalitis
- Sponsor
- India Council of Medical Research
- Enrollment
- 380
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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