Prevention of Infection in Indian Neonates - Phase II Probiotics Study

June 13, 2017 updated by: NICHD Global Network for Women's and Children's Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Orissa
      • Bhubaneswar, Orissa, India
        • Capital Hospital
      • Bhubaneswar, Orissa, India
        • Kalinga Hospital
      • Rourkela, Orissa, India
        • Ispat General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic Arm
Newborn infants' ≥ 35 weeks of gestation and ≥1800g, given L. plantarum preparations orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter.
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.
Other Names:
  • Gastroplan
Placebo Comparator: Control Arm
Newborn infants' ≥ 35 weeks of gestation and ≥1800g, receiving placebo preparations (a control solution of sterile 2.0 cc 5% dextrose-saline)orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter.
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.
Other Names:
  • Gastroplan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
Time Frame: 28 days
28 days
Clinical safety (including sepsis and death) and tolerance of a daily administration of oral L. plantarum probiotic supplement when used in healthy full-term neonates.
Time Frame: 28 days
28 days
Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.

Secondary Outcome Measures

Outcome Measure
Feasibility of the future community study (consent and retention rates, completeness of stool sampling, ability to complete the study in the home for infants discharged early).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

National Cancer Institute (NCI)
University of Maryland
All India Institute of Medical Sciences, New Delhi
National Institute of Dental and Craniofacial Research (NIDCR)
Bill and Melinda Gates Foundation
National Center for Complementary and Integrative Health (NCCIH)
Fogarty International Center of the National Institute of Health
RTI International
Global Network for Women's and Children's Health Research
TN Medical College, Mumbai
Department of Health and Family Welfare, Orissa
SCB Medical College, Cuttack
Capital Hospital, Bhubaneswar
Ispat General Hospital, Rourkela
Kalinga Hospital, Bhubaneswar

Investigators

  • Principal Investigator: Pinaki Panigrahi, M.D., University of Maryland School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN 07 Phase II
  • U01HD040574 (U.S. NIH Grant/Contract)
  • R01HD053719 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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