Prevention of Infection in Indian Neonates - Phase II Probiotics Study

PHASE2CompletedINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

July 31, 2005

Study Completion Date

August 31, 2006

Conditions
Sepsis
Interventions
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.

Trial Locations (3)

Unknown

Capital Hospital, Bhubaneswar

Kalinga Hospital, Bhubaneswar

Ispat General Hospital, Rourkela

All Listed Sponsors
collaborator

Global Network for Women's and Children's Health Research

OTHER

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Fogarty International Center of the National Institute of Health

NIH

collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

RTI International

OTHER

collaborator

All India Institute of Medical Sciences

OTHER

collaborator

TN Medical College, Mumbai

OTHER

collaborator

Department of Health and Family Welfare, Orissa

OTHER

collaborator

SCB Medical College, Cuttack

OTHER

collaborator

Capital Hospital, Bhubaneswar

OTHER

collaborator

Ispat General Hospital, Rourkela

OTHER

collaborator

Kalinga Hospital, Bhubaneswar

OTHER

collaborator

University of Maryland

OTHER

lead

NICHD Global Network for Women's and Children's Health

NETWORK

NCT00518596 - Prevention of Infection in Indian Neonates - Phase II Probiotics Study | Biotech Hunter | Biotech Hunter