Probiotics for Prevention Neonatal Infection

This study has been terminated.

(DSMB stopped the study due to early effectiveness)

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Pinaki Panigrahi, University of Nebraska

ClinicalTrials.gov Identifier:

NCT01214473

First received: September 30, 2010

Last updated: August 23, 2014

Last verified: August 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Neonatal Sepsis Sepsis Neonatal Infections	Other: Synbiotics Other: Maltodextrin	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Prevention of Neonatal Infection in the Indian Community Setting Using Probiotics

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Clinical sepsis and/or death [ Time Frame: During the first 60 days of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of culture proven sepsis (Gram-negative vs. Gram-positive) [ Time Frame: During the first 60 days of life ] [ Designated as safety issue: No ]
Incidence of other infections [ Time Frame: During the first 60 days of life ] [ Designated as safety issue: No ]
Effect on weight gain [ Time Frame: During the first 60 days of life ] [ Designated as safety issue: No ]


Enrollment:	4556
Study Start Date:	June 2007
Study Completion Date:	November 2013
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Other: Synbiotics Lactobacillus plantarum with fructo-oligosaccharide
Placebo Comparator: Placebo Once daily oral administration of maltodextrin for one week to newborn infants	Other: Maltodextrin Only maltodextrin as placebo

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.

Eligibility


Ages Eligible for Study:	up to 3 Days (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214473

Locations


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

Sponsors and Collaborators

University of Nebraska

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

Investigators


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

More Information


Responsible Party:	Pinaki Panigrahi, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier:	NCT01214473 History of Changes
Other Study ID Numbers:	332-10 FB 5R01HD053719
Study First Received:	September 30, 2010
Last Updated:	August 23, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:


Clinical sepsis Pneumonia Diarrhea Probiotics Synbiotics

Additional relevant MeSH terms:


Infection Communicable Diseases Sepsis Toxemia	Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2016

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