NCT06137235

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: FrieslandCampina · Industry
• Sex: All
• Age: 5 Days – 60 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	cows milk infant formula and follow-on formula with bioactive ingredients	infant formula and follow-on formula with bioactive ingredients
OTHER	standard cows milk infant formula and follow-on formula	standard cows milk infant formula and follow-on formula

Timeline

• Start date: 2023-12-18
• Primary completion: 2025-12-31
• Completion: 2027-12-01
• First posted: 2023-11-18
• Last updated: 2026-01-29

Locations

3 sites across 1 country: Greece