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

NCT ID: NCT06137235

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2027-12-31

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 ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF.

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 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.

Conditions

Growth; Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

test formula

infant formula and follow-on formula with bioactive ingredients

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

infant formula and follow-on formula with bioactive ingredients

control formula

standard infant formula and follow-on formula

Group Type: ACTIVE_COMPARATOR

standard cows milk infant formula and follow-on formula

Intervention Type: OTHER

standard cows milk infant formula and follow-on formula

Interventions

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

infant formula and follow-on formula with bioactive ingredients

Intervention Type: OTHER

standard cows milk infant formula and follow-on formula

standard cows milk infant formula and follow-on formula

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 60 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FrieslandCampina

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yannis Manios, Prof

Role: PRINCIPAL_INVESTIGATOR

Harokopio University

Locations

Harokopio University

Athens, , Greece

International Hellenic University

Thessaloniki, , Greece

University of Thessaly

Trikala, , Greece

Countries

Greece

Other Identifiers

Armadillo

Identifier Type: -

Identifier Source: org_study_id