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.

Inclusion criteria

• Infants ≥ 35 weeks and ≥1800g born in the hospital
• Infants > 12 hours and < 72 hours of age at enrollment
• Infants likely to be hospitalized for 5-7 days without antibiotic treatment
• Informed consent by one parent or guardian
• Infants begun breastfeeding

Exclusion criteria

• Antibiotic therapy prior to enrollment
• Evidence or suspicion of clinical sepsis before randomization
• Inability (as determined by the physician) to tolerate oral feeding of study supplement
• Presence of major congenital anomalies
• Infant's home is >30km away from hospital A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.