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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02865564
Other study ID # UPKLjubljana
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date March 2020

Study information

Verified date January 2024
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Days
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Lactobacillus reuteri DSM 17938

Placebo

Drug:
ampicillin and gentamicin


Locations

Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (2)

Lead Sponsor Collaborator
University Medical Centre Ljubljana University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional gastrointestinal dysfunction Questionnaire [/] At 6 months of age
Primary Composition of gut microbiota in infants - 1 [colony-forming units/ml; /] At 6 weeks after intervention
Primary Infants crying duration time Questionnaire [/] At 6 months of age
Primary Composition of gut microbiota in infants - 2 [colony-forming units/ml; /] At one year of age
Secondary Infant weight - 1 [kg]; to calculate body mass index At 6 months of age
Secondary Bone mineral density in infants - 1 Z-score [/] At 6 months of age
Secondary Infant height - 1 [m]; to calculate body mass index At 6 months of age
Secondary Infant weight - 2 [kg]; to calculate body mass index At 12 months of age
Secondary Bone mineral density in infants - 2 Z-score [/] At 12 months of age
Secondary Infant height - 2 [m]; to calculate body mass index At 12 months of age
Secondary Body composition of infants - 1 At 6 months of age
Secondary Body composition of infants - 2 At 12 months of age
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