Health Condition 1: null- Rotavirus induced diarrhea in children (6 to 24 months)
Conditions
Interventions
Intervention1: VSL#3 Sachets: Treated for 4 days (ORAL)
1) 5 Kg: 2 packets/day (180 billion bacteria/day)
2)5-10 Kg: 4 packets/day (360 billion bacteria/day)
3)10-15 Kg: 6 packets/day (540 billion b
Sponsors
CD Pharma India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a) Age: 6 to 24 months b) Acute diarrhoea: less than 72 hours from its onset c) Informed written consent of the patientsâ?? parents.
Exclusion criteria
Exclusion criteria: a) Presence of blood in faeces b) Less than 6 months and more than 24 months of age c) Severely dehydrated d) Signs and symptoms of systemic infection e) Chronic underlying disease f) Needs extensive care g) Body weight lower than 60% of standard weight, according to NCHS h) Pernicious vomiting or vomiting that would prevent administration of treatment i) Need of antibiotic administration j) Lack of informed consent from the parents and or the guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Number of stools per day b) Total duration of the diarrhoea expressed in hours (diarrhoea ends at the first soft stool or the last liquid stool) Timepoint: 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Quantity and duration (in hours) of IV rehydrating therapy b) Quantity and duration (in hours) of oral rehydrating therapy c) Total number of days of hospitalisationTimepoint: 4 days | — |
Countries
India
Contacts
Public ContactProf A P Dubey
Maulana Azad Medical College
Outcome results
None listed