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Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics

NCT ID: NCT02178267

Last Updated: 2014-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Infant, Premature, Diseases

Keywords

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Newborn, preterm, probiotic, resistant microorganisms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lactobacillus reuteri

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.

Group Type EXPERIMENTAL

Lactobacillus reuteri (biogai AB, Sweden)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Lactobacillus reuteri (biogai AB, Sweden)

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Probiotics were randomly given to newborn preterm infants.

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Dr Abdullah Kurt

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdullah Kurt, Neonatology

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Other Identifiers

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Kurt - 1

Identifier Type: -

Identifier Source: org_study_id