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

Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137235
• Other study ID #: Armadillo
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: FrieslandCampina
• Contact: Mirre Viskaal, PhD
• Phone: +31646911358
• Email: mirre.viskaal[@]frieslandcampina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Days to 60 Days

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Growth
• Infections

Intervention

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

Locations

Country	Name	City	State
Greece	Harokopio University	Athens
Greece	International Hellenic University	Thessaloníki
Greece	University of Thessaly	Tríkala

Sponsors (1)

Lead Sponsor	Collaborator
FrieslandCampina

Country where clinical trial is conducted

Greece, 

Outcome

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