se of VSL#3 (a new high concentration probiotic mixture) in the treatment of Rotavirus Diarrhea
Phase 3
Completed
- Conditions
- Health Condition 1: null- Rotavirus induced diarrhea in children (6 to 24 months)
- Registration Number
- CTRI/2008/091/000077
- Lead Sponsor
- CD Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)Number of stools per day <br/ ><br>b)Total duration of the diarrhoea expressed in hours (diarrhoea ends at the first soft stool or the last liquid stool) <br/ ><br>Timepoint: 4 days
- Secondary Outcome Measures
Name Time Method 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