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Probiotics in childhood viral encephalitis

Evaluation of safety and efficacy of adjuvant probiotics therapy in children with viral meningoencephalitis/ encephalitis: A randomized double blind controlled trial - PROVEC

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/11/002127
Enrollment
380
Registered
2011-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Admitted with a diagnosis of viral encephalitis

Interventions

Intervention1: Probiotic: Streptococcus thermophilus Bifidobacteria (B. longum, B. infantis, B. breve) Lactobacillus plantarum Lactobacillus delbrueckii subsp. bulgaricus Lactobacillus acidophilus L

Sponsors

India Council of Medical Research
Lead Sponsor

Eligibility

Inclusion 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

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 o Detailed

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Mortality in each group during hospital stay Adverse effects of therapy in both the groups Etiology of encephalitis in the whole population of enrolled patientsTimepoint: at discharge

Countries

India

Contacts

Public ContactPratibha Singhi

Post Graduate Institute of Medical Education and Research

pratibhasinghi@yahoo.com0172-2715619

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026