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Completed

NCT Number: NCT02865564

Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

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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Key information

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus reuteri DSM 17938

Dietary Supplement

Other names: BioGaia

Placebo

Dietary Supplement

ampicillin and gentamicin

Drug

Primary outcomes

  1. Functional gastrointestinal dysfunction

    Time frame: At 6 months of age

    Questionnaire [/]

  2. Composition of gut microbiota in infants - 1

    Time frame: At 6 weeks after intervention

    [colony-forming units/ml; /]

  3. Infants crying duration time

    Time frame: At 6 months of age

    Questionnaire [/]

  4. Composition of gut microbiota in infants - 2

    Time frame: At one year of age

    [colony-forming units/ml; /]

Secondary outcomes

  1. Infant weight - 1

    Time frame: At 6 months of age

    [kg]; to calculate body mass index

  2. Bone mineral density in infants - 1

    Time frame: At 6 months of age

    Z-score [/]

  3. Infant height - 1

    Time frame: At 6 months of age

    [m]; to calculate body mass index

  4. Infant weight - 2

    Time frame: At 12 months of age

    [kg]; to calculate body mass index

  5. Bone mineral density in infants - 2

    Time frame: At 12 months of age

    Z-score [/]

  6. Infant height - 2

    Time frame: At 12 months of age

    [m]; to calculate body mass index

  7. Body composition of infants - 1

    Time frame: At 6 months of age

  8. Body composition of infants - 2

    Time frame: At 12 months of age

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2016
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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