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 个研究点目标入组 380 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

发起方

India Council of Medical Research