University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
NCT Number: NCT02865564
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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All sexes
Interventional
Not applicable
Ljubljana, 1000, Slovenia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: BioGaia
Time frame: At 6 months of age
Questionnaire [/]
Time frame: At 6 weeks after intervention
[colony-forming units/ml; /]
Time frame: At 6 months of age
Questionnaire [/]
Time frame: At one year of age
[colony-forming units/ml; /]
Time frame: At 6 months of age
[kg]; to calculate body mass index
Time frame: At 6 months of age
Z-score [/]
Time frame: At 6 months of age
[m]; to calculate body mass index
Time frame: At 12 months of age
[kg]; to calculate body mass index
Time frame: At 12 months of age
Z-score [/]
Time frame: At 12 months of age
[m]; to calculate body mass index
Time frame: At 6 months of age
Time frame: At 12 months of age
University Medical Centre Ljubljana
Other
Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics on Emergence of Functional Gastrointestinal Disorders, Body Composition, Mineral Bone Density and Fecal Microbiota in Infancy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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