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

A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infections; Growth
• Intervention / Treatment: Other: cows milk infant formula and follow-on formula with bioactive ingredients; Other: standard cows milk infant formula and follow-on formula

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.

• Study Type: Interventional
• Enrollment (Estimated): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Harokopio University
  • Thessaloniki, Greece
    • International Hellenic University
  • Trikala, Greece
    • University of Thessaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test formula; infant formula and follow-on formula with bioactive ingredients	Other: cows milk infant formula and follow-on formula with bioactive ingredients; infant formula and follow-on formula with bioactive ingredients
Active Comparator: control formula; standard infant formula and follow-on formula	Other: standard cows milk infant formula and follow-on formula; standard cows milk infant formula and follow-on formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight for age, compared to WHO growth curve, for test group only	until age of 6 months
infection-related morbidity episodes, parent-reported	number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group	6 - 12 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight for age, compared to WHO growth curve, for control group	until the age of 6 months
length	length in cm	until the age of 6 months
head circumference	head circumference in cm	until the age of 6 months
BMI	BMI in kg/m2	until the age of 6 months
product tolerance: GI comfort	GI comfort questionnaire	until the age of 6 months
product tolerance: stool frequency and consistency	stool frequency and consistency questionnaire	until the age of 6 months
product tolerance: product intake	product intake (ml/feeding, ml/day)	until the age of 6 months
Duration of infection-related episodes	duration of parental-reported respiratory and gut infection-related symptoms in summed days	6 - 12 months of age
infection-related morbidity episodes, physician-diagnosed	number of physician-diagnosed respiratory and gut infection-related symptoms	6 - 12 months of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight in kg	at the age of 2 and 3 years
length	length in m	at the age of 2 and 3 years
head circumference	head circumference in cm	at the age of 2 and 3 years
BMI	BMI in kg/m2	at the age of 2 and 3 years
morbidity data	number of morbidity episodes	between 2 and 3 years of age
development	developmental assessment via Bayley-4	at 2 and 3 years of age

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Investigators: Principal Investigator: Yannis Manios, Prof, Harokopio University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: infections; growth; infant nutrition; gut comfort; product tolerance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections
• Other Study ID Numbers: Armadillo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No