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

FrieslandCampina

Status: Active, not recruiting

Conditions: Infections; Growth

Treatments: Other: standard cows milk infant formula and follow-on formula; Other: cows milk infant formula and follow-on formula with bioactive ingredients

Study type: Interventional

Funder types: Industry

Identifiers

NCT06137235

Armadillo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 456 estimated patients

Sex: All

Ages: 5 to 60 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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456 participants in 2 patient groups

test formula

Experimental group

Description:

infant formula and follow-on formula with bioactive ingredients

Treatment:

Other: cows milk infant formula and follow-on formula with bioactive ingredients

control formula

Active Comparator group

Description:

standard infant formula and follow-on formula

Treatment:

Other: standard cows milk infant formula and follow-on formula