Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement
Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement
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 infection in young children in south India, prevent intestinal damage and overall
 result in lower infection rates and better gut function. This trial will evaluate the
 efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or
 antibody fragments expressed in yeast or placebo are given daily as a food supplement to
 children between the ages of 6 and 12 months. The children will followed for one year and
 rates of rotavirus diarrhoea, antibody responses and gut function will be compared between
 children receiving antibody fragments or placebo.
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 receive supplementation with ARP or placebo, and will be followed for a period
 of one year, with weekly home visits and monitoring of all episodes of diarrhoea. In
 addition, every two weeks, surveillance stool samples will be collected and tested for
 rotavirus to identify asymptomatic infections by PCR. All episodes of diarrhoea will be
 investigated intensively for bacterial, viral and parasitic agents of diarrhoea using both
 conventional and molecular techniques and all cases will be treated appropriately at the
 study clinic or referral hospital as required. Monthly anthropometric measurements will be
 carried out to estimate rates of growth and to identify growth faltering. Blood samples will
 be taken at 4, 8 and 12 months for estimation of anti-rotavirus IgA and IgG antibodies.
 Studies on intestinal absorption and permeability will be carried out at recruitment, 6 and
 12 months by the lactulose:mannitol test (measured by HPLC detection of sugars). All
 rotavirus strains obtained will be characterized by genotyping.
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 exclusively 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