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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Active Comparator | Bifidobacterium bifidum and human milk oligosaccharides (HMOs) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic Supplement | Dietary Supplement | Bifidobacterium bifidum and human milk oligosaccharides (HMOs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI at 24 months of age | Child's body mass index (BMI) at the age of 24 months | From enrollment to 24 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Child's height at the age of 6, 12, 18, and 24 months | From enrollment to 24 months of age |
| Weight | Child's weight at the age of 6, 12, 18, and 24 months |
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Inclusion Criteria:
Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paula Tähtinen, MD, PhD | Contact | +358-2-3130746 | paula.tahtinen@utu.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku | Recruiting | Turku | Valitse Maakunta. | 20780 | Finland |
IPD may be shared for research purposes upon special request to the PI
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized, placebo-controlled trial
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| Placebo | Other | Maltodextrin |
|
| From enrollment to 24 months of age |
| Growth velocity | Child's growth velocity at 2-3 months of age | From enrollment to 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 | From enrollment to 24 months of age |
| Mother's microbiome | The function and composition of the mother's gut, nasal, and mouth microbiome when the child is 2 and 6 months of age | From enrollment to 6 months after giving birth |
| Breast milk microbiome | The composition of breast milk's microbiome when the child is 2 and 6 months of age | From enrollment to 6 months of age |
| Hormonal levels | 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 | From enrollment to 6 months of age |
| Inflammatory markers | 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 | From enrollment to 6 months of age |
| Respiratory tract infections | Respiratory tract infections by the age of 24 months | From enrollment to 24 months of age |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |