Healthy Newborn Infants
Conditions
Keywords
antibiotics, human milk oligosaccharides, probiotics, newborn, microbiome, microbiota, obesity, infectious diseases
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic Supplement
Bifidobacterium bifidum and human milk oligosaccharides (HMOs)
OTHERPlacebo
Maltodextrin
Sponsors
Lallemand Health Solutions
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
2 Hours to No maximum
Healthy volunteers
No
Inclusion criteria
Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI at 24 months of age | From enrollment to 24 months of age | Child's body mass index (BMI) at the age of 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | From enrollment to 24 months of age | Child's weight at the age of 6, 12, 18, and 24 months |
| Growth velocity | From enrollment to 3 months of age | Child's growth velocity at 2-3 months of age |
| Child's microbiome | From enrollment to 24 months of age | The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months |
| Mother's microbiome | From enrollment to 6 months after giving birth | The function and composition of the mother's gut, nasal, and mouth microbiome when the child is 2 and 6 months of age |
| Height | From enrollment to 24 months of age | Child's height at the age of 6, 12, 18, and 24 months |
| Hormonal levels | From enrollment to 6 months of age | Child's hormonal levels (testosterone, sex hormone-binding globulin, luteinizing hormone and follicle-stimulating hormone) at birth and at the age of 2 and 6 months |
| Inflammatory markers | From enrollment to 6 months of age | Systemic inflammation markers (cytokines, C-reactive protein, soluble urokinase-type plasminogen activator receptor and haptoglobulin) at birth and at the age of 2 and 6 months |
| Respiratory tract infections | From enrollment to 24 months of age | Respiratory tract infections by the age of 24 months |
| Breast milk microbiome | From enrollment to 6 months of age | The composition of breast milk's microbiome when the child is 2 and 6 months of age |
Countries
Finland
Contacts
Primary ContactPaula Tähtinen, MD, PhD
Outcome results
None listed