Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, T… (NCT06137235) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
Greece456 participantsStarted 2023-12-18
Plain-language 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.
Who can participate
Age range5 Days – 60 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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