Probiotics for Prevention Neonatal Infection

August 19, 2023 updated by: University of Nebraska

Prevention of Neonatal Infection in the Indian Community Setting Using Probiotics

Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Sepsis accounts for 50% of deaths among community born (and 20% of mortality among hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial resistance, which is increasingly restricting the therapeutic options for medical care providers. Friendly bacteria called "Probiotics" have been used in multiple infectious and inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in many fruits and vegetables and also in human breast milk. These sugars reach the colon undigested and serve as food for the friendly bacteria. The current study uses a probiotic preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to prevent neonatal infections. Currently no conclusive data are available on the utility of probiotics in such conditions. If successful, such inexpensive preventive therapy can be made available to general public in resource poor countries. Similar preparations can also be used in the western world to prevent similar infectious conditions of the neonatal period, especially in preterm infants where sepsis continues to be a major cause of hospital stay and death.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Our current study is an attempt to put the well known concept of probiotics through rigorous scientific testing before it could be recommended as a prophylactic therapy against neonatal infections. The study will be conducted in India in 8,442 infants who will receive once daily dosing of probiotics for one week. They will be followed for 60 days at home. We have designed the study with enough power to detect a 20% drop in the incidence rate and plan to collect multiple other demographic data from the mothers and infants to help us discern the possible contribution of other confounding risk factors that have been implicated as cofactors in neonatal infection and death.

This will be a randomized controlled clinical trial involving probiotics (Lactobacillus plantarum 10 billion bacteria and 150 mg of fructo-oligosaccharide). We will use our well established three tier monitoring system in the villages. Infants with any adverse event (including sepsis and other infections) will be brought to attached study hospitals for clinical care. Blood and/or CSG culture will be done using Bactec blood culture system and treatment will be provided based on clinical judgment and microbiological analysis of the blood/CSF and/or other findings such as chest X-ray. Data entry will be done on site and transmitted to the principal investigator's institution in the U.S. A data safety monitoring board convened by expert clinicians, neonatologists, and biostatisticians will monitor the study yearly and more frequently if required. Analyzed data will be published in appropriate journals.

Study Type

Interventional

Enrollment (Actual)

4556

Phase

  • Not Applicable

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
    • Odisha
      • Rourkela, Odisha, India, 769002
        • Ispat General Hospital
    • Orissa
      • Bhubaneswar, Orissa, India, 751009
        • Center for Advanced Research on Alternative Medicine

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

1 day to 3 days (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All newborn infants in the community >24 hours and <72 hours of age
  • 2000 g at birth
  • Breastfeeding begun by 24 hr of life
  • Able to tolerate oral feeds
  • Informed consent by parent or guardian

Exclusion Criteria:

  • Evidence or suspicion of clinical sepsis before the baby is randomized
  • Not on breast feeding by 24 hr
  • Inability to establish oral feeds (in case of maternal death or ailment)
  • Presence of major congenital anomalies

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Once daily oral administration of a probiotic preparation (1 billion cells of Lactobacillus plantarum and 150 mg of fructooligosaccharides) for one week to newborn infants
Dietary supplement: Synbiotics
Lactobacillus plantarum with fructo-oligosaccharide
Placebo Comparator: Placebo
Once daily oral administration of maltodextrin for one week to newborn infants
Dietary supplement: Maltodextrin
Only maltodextrin as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical sepsis and/or death
Time Frame: During the first 60 days of life
Incidence of clinical sepsis and/or death
During the first 60 days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Culture proven sepsis
Time Frame: During the first 60 days of life
Incidence of culture proven sepsis (Gram-negative vs. Gram-positive)
During the first 60 days of life
Other infections
Time Frame: During the first 60 days of life
Incidence of other infections
During the first 60 days of life
Weight gain
Time Frame: During the first 60 days of life
Weight gained or lost
During the first 60 days of life

Collaborators and Investigators

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

Sponsor

University of Nebraska

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Pinaki Panigrahi, MD,PhD, University of Nebraska

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

June 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimated)

October 5, 2010

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 19, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0332-10 FB
  • 5R01HD053719 (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.

Subscribe