Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

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

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-03-31

Brief Summary

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The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic therapy on development of gut microbiota, functional gastrointestinal disorders of infancy, weight gain and body composition.

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Detailed Description

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The study is double-blind, placebo-controlled randomised trial and is composed from two parts. First part of the study aims to examine any difference in gut microbiota after postnatal antibiotic administration between the neonates who received probiotic Lactobacillus reuteri DSM 17938 or placebo and to compare the gut microbiota of patients to microbiota of healthy newborns. Second part of the study aims to determine whether probiotic L. reuteri DSM 17938 supplementation to antibiotic therapy has any beneficial influence on incidence of functional gastrointestinal disorders of infancy and body composition and bone density 6 weeks and one year after inclusion in the study.

Additionally the associations of the clinical parameters with the composition and developmental characteristics of fecal microbiota during antibiotic treatment in children will be evaluated; relevant clinical data such as mode of delivery, child's nutrition, health problems, growth and developmental attributes which could be found associated with fecal microbial community, will be tracked and statistically evaluated for the investigated population.

Conditions

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Gastrointestinal Diseases Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

The intervention group will receive 5 drops, a minimum of 100 million live Lactobacillus reuteri DSM 17938 a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

ampicillin and gentamicin

Intervention Type DRUG

Placebo group

Placebo group will receive 5 drops of maltodextrin in the some oil suspension a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

ampicillin and gentamicin

Intervention Type DRUG

Interventions

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Lactobacillus reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

ampicillin and gentamicin

Intervention Type DRUG

Other Intervention Names

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BioGaia

Eligibility Criteria

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Inclusion Criteria

* term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection

Exclusion Criteria

* gestational age under 37 weeks
* birth weight less than 2500 grams
* congenital malformations/syndromes
* perinatal hypoxia
* who had received probiotics before the randomization
* have had cow's milk protein allergy diagnosed during the study
* patient who will be treated with antibiotic for less than 5 days

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No