Status:
ACTIVE_NOT_RECRUITING
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
Lead Sponsor:
FrieslandCampina
Conditions:
Growth
Infections
Eligibility:
All Genders
5-60 years
Phase:
NA
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 ingredi...
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 ingredi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT06137235
Start Date
December 18 2023
End Date
December 1 2025
Last Update
August 8 2025
Active Locations (3)
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1
Harokopio University
Athens, Greece
2
International Hellenic University
Thessaloniki, Greece
3
University of Thessaly
Trikala, Greece