Prevention of Infection in Indian Neonates - Phase II Probiotics Study
Phase II is a hospital based intervention (n = 297 infants) measuring the colonizing
ability, safety, and tolerance of a probiotic supplement, Lactobacillus plantarum in the
neonatal gut. Newborn infants ≥ 35 weeks of gestation will be randomized to receive either
L. plantarum preparations (containing 109 organisms) or placebo preparations orally once a
day for the first 7 days of life. The final stage of the project will be a community-based
randomized double-blind placebo-controlled trial of L. plantarum enrolling over 8,000
newborns to examine the efficacy of probiotic supplementation in reducing neonatal infection
in Indian neonates.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
Pinaki Panigrahi, M.D.
University of Maryland
United States: Federal Government
GN 07 Phase II