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In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF.
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included <2mo of age. An exploratory follow-up assessment will be done at the age of 2 and 3 years to study sustained health effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test formula | Experimental | infant formula and follow-on formula with bioactive ingredients |
|
| control formula | Active Comparator | standard infant formula and follow-on formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cows milk infant formula and follow-on formula with bioactive ingredients | Other | infant formula and follow-on formula with bioactive ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| weight | weight for age, compared to WHO growth curve, for test group only | until age of 6 months |
| infection-related morbidity episodes, parent-reported | number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group | 6 - 12 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| weight | weight for age, compared to WHO growth curve, for control group | until the age of 6 months |
| length | length in cm | until the age of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| weight | weight in kg | at the age of 2 and 3 years |
| length | length in m | at the age of 2 and 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yannis Manios, Prof | Harokopio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harokopio University | Athens | Greece | ||||
| International Hellenic University |
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| standard cows milk infant formula and follow-on formula | Other | standard cows milk infant formula and follow-on formula |
|
| head circumference | head circumference in cm | until the age of 6 months |
| BMI | BMI in kg/m2 | until the age of 6 months |
| product tolerance: GI comfort | GI comfort questionnaire | until the age of 6 months |
| product tolerance: stool frequency and consistency | stool frequency and consistency questionnaire | until the age of 6 months |
| product tolerance: product intake | product intake (ml/feeding, ml/day) | until the age of 6 months |
| Duration of infection-related episodes | duration of parental-reported respiratory and gut infection-related symptoms in summed days | 6 - 12 months of age |
| infection-related morbidity episodes, physician-diagnosed | number of physician-diagnosed respiratory and gut infection-related symptoms | 6 - 12 months of age |
| head circumference | head circumference in cm | at the age of 2 and 3 years |
| BMI | BMI in kg/m2 | at the age of 2 and 3 years |
| morbidity data | number of morbidity episodes | between 2 and 3 years of age |
| development | developmental assessment via Bayley-4 | at 2 and 3 years of age |
| Thessaloniki |
| Greece |
| University of Thessaly | Trikala | Greece |
| ID | Term |
|---|---|
| D007239 | Infections |
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