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NCT07867509

PHASE3

A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants.

Sponsor: FrieslandCampina

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant formula. The key secondary outcome is to study sIgA levels from faecal samples at endline while controlling for baseline levels. Parents of the enrolled infants will be asked to complete a diary, let their infant undergo physical examinations and complete questionnaire and feed their infant the assigned infant formula

Official title: A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Bio-active Ingredients on Immune Parameters, Gut Health and Growth in Healthy Term Infants.

Key Details

Gender

All

Age Range

Any - 21 Days

Study Type

INTERVENTIONAL

Enrollment

387

Start Date

2027-01

Completion Date

2028-12

Last Updated

2026-10-09

Healthy Volunteers

Yes

Conditions

Infant ALL

Interventions

COMBINATION_PRODUCT

Infant Formula

the experimental formula contains milk fat, MFGM, Lactoferrin, GOS and 2'FL

COMBINATION_PRODUCT

Infant Formula

Standard infant formula complying to (inter-)national legislation

COMBINATION_PRODUCT

Breastfeeding

Exclusively breastfeeding

Inclusion Criteria: * Full-term infants (born between gestational age ≥ 37 weeks\[Lv45.1\] - 42 weeks). * Healthy birthweight (according to WHO Child Growth Standards): 2500 g ≤ birthweight ≤ 4200 g (corresponding to Z-scores between the range of -2 SD and +2 SD) * Boys and girls * Apparently healthy at birth and screening * Weight-for-age Z-score (WAZ) at screening within the healthy range according to WHO Child Growth Standards (i.e. -2 SD ≤WAZ≤ 2SD) * Age at enrolment: ≤21 days of age\[Lv46.1\] * For formula groups: Infants should be exclusively formula fed for at least 3 days prior to inclusion. * For breastfed group: exclusively breastfeeding infant and the intention to keep exclusively breastfeeding during study period * Being available for follow up during the duration of the study * Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years * Intention to exclusively feed infant milk (formula or human milk). No weaning during study period. Exclusion Criteria: * Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. GI disorders, growth, immune-related diseases) * 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 sole source of nutrition for their child until the end of the study period * Past use of supplementation with probiotic supplements (e.g. Biogaia ProTectis Baby Drops, ProBiovit, Intermed Biolact) or infant formula containing probiotics or any specialties IFT \[(partially) hydrolysates, comfort formula, etc.\] * Antibiotic use in the first month of life (except exposure resulting from maternal peripartum antibiotic administration, which will be recorded) * Multiple gestation (e.g. twins, triplets or higher-order multiple births)

Clinical Research Directory

A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria