NCT00518596

Prevention of Infection in Indian Neonates - Phase II Probiotics Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: NICHD Global Network for Women's and Children's Health · Network
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Accepted

Summary

India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.

Detailed description

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic supplementation (Lactobacillus plantarum)	GastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe.

Timeline

• Start date: 2005-07-01
• Completion: 2006-08-01
• First posted: 2007-08-21
• Last updated: 2017-06-15

Locations

3 sites across 1 country: India