Know Cancer

forgot password

Prevention of Infection in Indian Neonates - Phase II Probiotics Study

Phase 2
72 Hours
Not Enrolling

Thank you

Trial Information

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.

Outcome Time Frame:

28 days

Principal Investigator

Pinaki Panigrahi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland


United States: Federal Government

Study ID:

GN 07 Phase II



Start Date:

July 2005

Completion Date:

August 2006

Related Keywords:

  • Sepsis
  • Neonatal
  • Sepsis
  • Global Network
  • Probiotics
  • India
  • International
  • Maternal and child health
  • Sepsis