Effect of oral probiotic supplementation during pregnancy and lactation in modulating immune response in breast milk, fetus and neonate
Phase 2
Completed
- Registration Number
- CTRI/2013/04/003577
- Lead Sponsor
- ext Gen Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 267
Inclusion Criteria
Pregnant women with
•Singleton gestation
•No high risk factor booked in pregnancy.
•Mothers who are staying in Delhi and not migrating out after delivery.
•Willing to follow up
•Willing for exclusive breast feeding for at least 14 weeks post delivery
Exclusion Criteria
•Twin gestation
•At risk of preterm birth
•Very young (19yrs) /old (40yrs)
•Non compliant /not willing to follow up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of mothers who will have detectable levels of immune markers in mature breast milk including cytokines-IFN-?, IL-6, IL-10 antimicrobial agents- Total IgA, Lactoferrin and growth factors –IGF-1Timepoint: At time of delivery, Follow up at 1,6,10,14 weeks post-partum
- Secondary Outcome Measures
Name Time Method 1.Proportion of fetus and neonates who will have detectable levels of immune markers in cord blood, including cytokines -IFN-?, IL-6, IL-10, and growth factors - IGF-1. <br/ ><br>2.Proportion of neonates with protective levels of antibody against Hepatitis B surface antigen (anti-HbsAg) 6 weeks after vaccination with Hepatitis B vaccination. <br/ ><br>Timepoint: At time of delivery, Follow up at 1,6,10,14 weeks post-partum