Clinical trial NCT02865564: Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Colic
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
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
First posted: 2016-08-12
Enrollment: 98
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional gastrointestinal dysfunction
timeFrame: At 6 months of age
measure: Composition of gut microbiota in infants - 1
timeFrame: At 6 weeks after intervention
measure: Infants crying duration time
timeFrame: At 6 months of age
measure: Composition of gut microbiota in infants - 2
timeFrame: At one year of age
Secondary outcomes:
measure: Infant weight - 1
timeFrame: At 6 months of age
measure: Bone mineral density in infants - 1
timeFrame: At 6 months of age
measure: Infant height - 1
timeFrame: At 6 months of age
measure: Infant weight - 2
timeFrame: At 12 months of age
measure: Bone mineral density in infants - 2
timeFrame: At 12 months of age
measure: Infant height - 2
timeFrame: At 12 months of age
measure: Body composition of infants - 1
timeFrame: At 6 months of age
measure: Body composition of infants - 2
timeFrame: At 12 months of age
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References: