Growth, Infections
Conditions
Keywords
infant nutrition, growth, gut comfort, product tolerance, infections
Brief summary
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.
Detailed description
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.
Interventions
OTHERcows milk infant formula and follow-on formula with bioactive ingredients
infant formula and follow-on formula with bioactive ingredients
OTHERstandard cows milk infant formula and follow-on formula
standard cows milk infant formula and follow-on formula
Sponsors
FrieslandCampina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Days to 60 Days
Healthy volunteers
Yes
Inclusion criteria
* Full-term infants * Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g * Boys and girls * Apparently healthy at birth and screening * Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards * Age at enrolment: ≤60 days of age * If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion * If 1 month \< age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2 * Being available for follow up until the age of 12 months * Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years
Exclusion criteria
* Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID)) * Incapability of parents to comply with the study protocol * Illiterate parents (i.e. not able to read and write in local language) * Participation in another clinical trial * Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months * Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight | until age of 6 months | weight for age, compared to WHO growth curve, for test group only |
| infection-related morbidity episodes, parent-reported | 6 - 12 months of age | number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of infection-related episodes | 6 - 12 months of age | duration of parental-reported respiratory and gut infection-related symptoms in summed days |
| weight | until the age of 6 months | weight for age, compared to WHO growth curve, for control group |
| length | until the age of 6 months | length in cm |
| head circumference | until the age of 6 months | head circumference in cm |
| BMI | until the age of 6 months | BMI in kg/m2 |
| product tolerance: GI comfort | until the age of 6 months | GI comfort questionnaire |
| product tolerance: stool frequency and consistency | until the age of 6 months | stool frequency and consistency questionnaire |
| infection-related morbidity episodes, physician-diagnosed | 6 - 12 months of age | number of physician-diagnosed respiratory and gut infection-related symptoms |
| product tolerance: product intake | until the age of 6 months | product intake (ml/feeding, ml/day) |
Countries
Greece
Contacts
PRINCIPAL_INVESTIGATORYannis Manios, Prof
Harokopio University
Outcome results
None listed