Community based prevention of rotavirus gastroenteritis by a functional food supplement
Phase 2
Completed
- Registration Number
- CTRI/2010/091/003002
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
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 breast fed for at least four months
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rotavirus gastroenteritisTimepoint: Total number of episodes in the 12 month follow up period
- Secondary Outcome Measures
Name Time Method IgA and IgG antibody response to rotavirus at 4, 8 and 12 month <br/ ><br>height for age Z score at 6 and 12 months <br/ ><br>Intestinal function by lactulose:mannitol test at 3, 6 9 and 12 months <br/ ><br>Characterization of circulating rotavirus strains <br/ ><br>Timepoint: As specified above and over entire follow up duration