None listed
Conditions
Interventions
Intervention1: Lactobacillus GG (contents of 1 capsule once daily in 20 ml of milk) for 6 weeks: The factorial design will result in two arms receiving each of the two interventions (zinc or probiotic
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: • Infants 35-41 days old. • Live in area under surveillance. • Current weight >=3.2 kg. • No syndromic evidence of immunocompromise. • No prior illness requiring hospitalization. • No current medical condition as determined by medical doctor which precludes study involvement. • Available for follow up for duration of study (through approximately 14 weeks of age). • Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent.
Exclusion criteria
Exclusion criteria: • Child has history of atopic symptoms. • Child has a known digestive system defect. • Child has history of chronic diarrhea. • Child has major congenital anomalies. • Child has received a prior dose of rotavirus vaccine. • Child has received a prior dose of polio vaccine (beyond the birth dose).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the serologic immune response to rotavirus vaccine among Indian infants receiving zinc supplementation or a probiotic given daily for a week prior to the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc or probiotic placebo Timepoint: 4 weeks after the second dose of immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the serologic immune response to oral polio vaccine among Indian infants receiving zinc or probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral polio vaccine compared to those receiving a zinc or probiotic placeboTimepoint: 4 weeks after the second dose of immunization | — |
Countries
India
Contacts
Public ContactGagandeep Kang
Christian Medical College, Vellore
Outcome results
None listed