Effect of oral probiotic supplementation during pregnancy and lactation in modulating immune response in breast milk, fetus and neonate

Effects of oral probiotic supplementation during pregnancy and lactation in modulating immune response in breast milk, fetus, and neonate- A randomised double blind controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/04/003577

Enrollment

250

Registered

2013-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Probiotic capsule (Original De Simone Formulation): Probiotic capsule contains a mix of 8 different strains of freeze-dried lactic acid bacteria and bifidobacteria

each capsule containing not less than 112.5 billion CFU. Study Drug will be given orally 3 times a day starting from 34 weeks of gestation till 14 weeks postpartum. Control Intervention1: Placebo: ide

Eligibility

Inclusion criteria

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

Exclusion criteria: • Twin gestation • At risk of preterm birth • Very young (19yrs) /old (40yrs) • Non compliant /not willing to follow up

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 2. Proportion of neonates with protective levels of antibody against Hepatitis B surface antigen (anti-HbsAg) 6 weeks after vaccination with Hepatitis B vaccination. Timepoint: At time of delivery, Follow up at 1,6,10,14 weeks post-partum	—

Measure

Time frame

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. 2. Proportion of neonates with protective levels of antibody against Hepatitis B surface antigen (anti-HbsAg) 6 weeks after vaccination with Hepatitis B vaccination. Timepoint: At time of delivery, Follow up at 1,6,10,14 weeks post-partum

—

Countries

India

Contacts

Public ContactDr Neena Malhotra

All India Institute of Medical Sciences, New Delhi

malhotraneena@yahoo.com011-26593361

Outcome results