Status:
COMPLETED
Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement
Lead Sponsor:
Christian Medical College, Vellore, India
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
PHASE3
Brief Summary
Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The investigators hypothesize that use of a food based prophylactic will decrease incidence of rotavirus infecti...
Detailed Description
The study will be carried out in an urban slum area in Vellore, south India. Children between the ages of 6 and 12 months will be recruited for participation in the study. They will be randomized to r...
Eligibility Criteria
Inclusion
- Healthy child aged 6 to 12 months, families resident in the study area, willing to participate and available for follow up for a period of one year
- Normal birth weight (\> 2.5 kg), child exclusively breast fed for at least four months
Exclusion
- Families not available for a follow up period of one year
- Children with any atopic conditions
- Children with gross congenital anomalies including cardiovascular, renal or hepatic disease
- Children with syndromic or serological evidence of HIV infection
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01265355
Start Date
March 1 2011
End Date
June 1 2012
Last Update
February 4 2015
Active Locations (1)
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1
Christian Medical College
Vellore, Tamil Nadu, India, 632004