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Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics

Primary Purpose

Infant, Premature, Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactobacillus reuteri (biogai AB, Sweden)
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Premature, Diseases focused on measuring Newborn, preterm, probiotic, resistant microorganisms

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The study were included ≤36 weeks gestational age newborn preterm infants requiring antibiotic treatment and/or prophylaxis.

Exclusion Criteria:

  • Newborn preterm infants who are congenital anomalies and not require antibiotic therapy and undergoing intestinal operation were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lactobacillus reuteri

    Arm Description

    The study was performed by two groups. And these groups were constituted from the newborn preterm infants who are received probiotics (Lactobacillus reuteri) and no probiotics.

    Outcomes

    Primary Outcome Measures

    The use of probiotics in newborn preterm infants receiving antibiotics will be investigated type of resistant microorganisms in the flora of intestinal and nasal.
    The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors such as developmental immaturity of the immune system, encountering with the flora of neonatal intensive care unit, exposure to diagnostic and therapeutic interventional procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of natural and mucosal immunity of intestine in newborns preterm during postnatal period. Exposure to these factors, newborn preterm infants' life threatens especially to change the development of the normal intestinal flora and intestinal immunity. Many randomized controlled studies reported that probiotics reduce intestinal inflammatory process and to prevent colonization with pathogenic microorganisms of the intestines . In this study, we investigated the effect use of probiotic on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics.

    Secondary Outcome Measures

    Types Of Resistant Microorganisms In The Culture
    In the culture, all possible resistant microorganisms such as methicillin-resistant Staphylococci aureus, Enterococcus, Klebsiella spp, Escherichia coli, Pseudomonas aeruginosa, Enterobacter, Acinetobacter, Serratia, Candida species were investigated.

    Full Information

    First Posted
    June 13, 2014
    Last Updated
    June 27, 2014
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02178267
    Brief Title
    Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics
    Official Title
    Effect Of Probiotics On Resistant Bacteria Colonization Preterm Newborn Infants Receiving Antibiotics In Neonatal Intensive Care Unit
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baskent University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the use of probiotics in preterm neonates in neonatal intensive care units expect to prevent colonization by resistant microorganisms.
    Detailed Description
    The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors such as developmental immaturity of the immune system, encountering with the flora of neonatal intensive care unit, exposure to diagnostic and therapeutic interventional procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of natural and mucosal immunity of intestine in newborns preterm during postnatal period. Exposure to these factors, newborn preterm infants' life threatens especially to change the development of the normal intestinal flora and intestinal immunity. Many randomized controlled studies reported that probiotics reduce intestinal inflammatory process and prevent colonization with pathogenic microorganisms of the intestines . In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infant, Premature, Diseases
    Keywords
    Newborn, preterm, probiotic, resistant microorganisms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lactobacillus reuteri
    Arm Type
    Experimental
    Arm Description
    The study was performed by two groups. And these groups were constituted from the newborn preterm infants who are received probiotics (Lactobacillus reuteri) and no probiotics.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus reuteri (biogai AB, Sweden)
    Other Intervention Name(s)
    Probiotics were randomly given to newborn preterm infants.
    Intervention Description
    Lactobacillus reuteri (biogai AB, Sweden) was given to probiotic group, same way to all newborn newborn preterm infants, directly oral feeding and without any along with a mixture, admission following the in nicu, as a daily dose 1x108 cfu / day (1x5 drops / day) during hospitalization
    Primary Outcome Measure Information:
    Title
    The use of probiotics in newborn preterm infants receiving antibiotics will be investigated type of resistant microorganisms in the flora of intestinal and nasal.
    Description
    The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors such as developmental immaturity of the immune system, encountering with the flora of neonatal intensive care unit, exposure to diagnostic and therapeutic interventional procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of natural and mucosal immunity of intestine in newborns preterm during postnatal period. Exposure to these factors, newborn preterm infants' life threatens especially to change the development of the normal intestinal flora and intestinal immunity. Many randomized controlled studies reported that probiotics reduce intestinal inflammatory process and to prevent colonization with pathogenic microorganisms of the intestines . In this study, we investigated the effect use of probiotic on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics.
    Time Frame
    Up to 12 month
    Secondary Outcome Measure Information:
    Title
    Types Of Resistant Microorganisms In The Culture
    Description
    In the culture, all possible resistant microorganisms such as methicillin-resistant Staphylococci aureus, Enterococcus, Klebsiella spp, Escherichia coli, Pseudomonas aeruginosa, Enterobacter, Acinetobacter, Serratia, Candida species were investigated.
    Time Frame
    Up to 12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    28 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The study were included ≤36 weeks gestational age newborn preterm infants requiring antibiotic treatment and/or prophylaxis. Exclusion Criteria: Newborn preterm infants who are congenital anomalies and not require antibiotic therapy and undergoing intestinal operation were excluded from the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdullah Kurt, Neonatology
    Organizational Affiliation
    Baskent University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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