Clinical trial NCT06137235: Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Growth
Infections
Keywords: infant nutrition
growth
gut comfort
product tolerance
infections
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 456
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: weight
timeFrame: until age of 6 months
measure: infection-related morbidity episodes, parent-reported
timeFrame: 6 - 12 months of age
Secondary outcomes:
measure: weight
timeFrame: until the age of 6 months
measure: length
timeFrame: until the age of 6 months
measure: head circumference
timeFrame: until the age of 6 months
measure: BMI
timeFrame: until the age of 6 months
measure: product tolerance: GI comfort
timeFrame: until the age of 6 months
measure: product tolerance: stool frequency and consistency
timeFrame: until the age of 6 months
measure: product tolerance: product intake
timeFrame: until the age of 6 months
measure: Duration of infection-related episodes
timeFrame: 6 - 12 months of age
measure: infection-related morbidity episodes, physician-diagnosed
timeFrame: 6 - 12 months of age
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
city: Thessaloníki
country: Greece
facility: International Hellenic University
city: Tríkala
country: Greece
facility: University of Thessaly
Study officials:
affiliation: Harokopio University
name: Yannis Manios, Prof
role: PRINCIPAL_INVESTIGATOR
References: