Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections

Launched by FRIESLANDCAMPINA · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how an infant formula and follow-on formula that contain special ingredients (called bio-active ingredients) affect the growth, comfort, and health of healthy infants. Researchers want to see if these formulas help babies gain weight properly, are easy for them to digest, and reduce the number of infections they might get. The study will compare babies using these special formulas to those who are using a regular formula.

To take part in this trial, infants must be full-term, healthy, and between 5 and 60 days old. They should have a normal birth weight and must be exclusively fed formula for at least five days before joining the study. Parents or guardians will need to provide written consent, and they should be available for follow-up visits until the baby is one year old. It's important to note that babies with certain health issues, like allergies to milk or other serious conditions, won't be eligible. If you decide to join, your baby will be provided with the study formula exclusively until they reach 12 months old, and you’ll be helping researchers learn more about infant nutrition!

Gender

ALL

Eligibility criteria

• 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