About this trial
The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Chorioamnionitis
Pre-eclampsia and hepatogestosis
Suspected malformation or serious condition of the foetus and neonates
Serious infection or other conditions not permitting breast milk feeding
Trial design
Parallel
Treatments tested in this trial
Synbiotic Supplement
Dietary supplementBifidobacterium bifidum and human milk oligosaccharides (HMOs)
Placebo
Other interventionMaltodextrin
Treatment groups
Trial outcomes
Primary outcomes
BMI at 24 months of age
Child's body mass index (BMI) at the age of 24 months
Secondary outcomes
Height
Child's height at the age of 6, 12, 18, and 24 months
Weight
Child's weight at the age of 6, 12, 18, and 24 months
Growth velocity
Child's growth velocity at 2-3 months of age
Child's microbiome
The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months
Sponsors and contacts
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Turku University Hospital
Lead sponsor
Lallemand Health Solutions
Collaborator