Gastrointestinal Diseases, Colic
Conditions
Keywords
Probiotics, Anti-Bacterial Agents, Infant, Newborn, Gastrointestinal Microbiome, Colic, Gastrointestinal Diseases, Body Composition, Bone Density, Randomized Controlled Trial, Lactobacillus reuteri, Pediatrics, Feces, ultrasonography, High-Throughput Nucleotide Sequencing, Electric Impedance, Surveys and Questionnaires
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri DSM 17938
DIETARY_SUPPLEMENTPlacebo
Sponsors
University of Ljubljana
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional gastrointestinal dysfunction | At 6 months of age | Questionnaire \[/\] |
| Composition of gut microbiota in infants - 1 | At 6 weeks after intervention | \[colony-forming units/ml; /\] |
| Infants crying duration time | At 6 months of age | Questionnaire \[/\] |
| Composition of gut microbiota in infants - 2 | At one year of age | \[colony-forming units/ml; /\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density in infants - 2 | At 12 months of age | Z-score \[/\] |
| Infant height - 2 | At 12 months of age | \[m\]; to calculate body mass index |
| Infant weight - 1 | At 6 months of age | \[kg\]; to calculate body mass index |
| Body composition of infants - 2 | At 12 months of age | — |
| Body composition of infants - 1 | At 6 months of age | — |
| Bone mineral density in infants - 1 | At 6 months of age | Z-score \[/\] |
| Infant height - 1 | At 6 months of age | \[m\]; to calculate body mass index |
| Infant weight - 2 | At 12 months of age | \[kg\]; to calculate body mass index |
Countries
Slovenia
Outcome results
None listed