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

Not Applicable

Recruiting

• Conditions: Growth; Infections
• Interventions: Other: cows milk infant formula and follow-on formula with bioactive ingredients; Other: standard cows milk infant formula and follow-on formula

• Registration Number: NCT06137235
• Lead Sponsor: FrieslandCampina

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.

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-18
• Study Start: 2023-12-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 456

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test formula	cows milk infant formula and follow-on formula with bioactive ingredients	infant formula and follow-on formula with bioactive ingredients
control formula	standard cows milk infant formula and follow-on formula	standard infant formula and follow-on formula

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

International Hellenic University; 🇬🇷 Thessaloníki, Greece

Harokopio University; 🇬🇷 Athens, Greece

University of Thessaly; 🇬🇷 Tríkala, Greece