NCT04306263

Effect of a New Infant Formula With Specific Ingredients

Evaluation of the Effect of a New Infant Formula With Specific Ingredients on the Development of the Immune System and the Gastrointestinal Health of the Infant

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: Laboratorios Ordesa · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.

Detailed description

Nowadays, almost all commercial infant formulas resemble the "gold standard" of breast milk in terms of composition of essential nutrients, but it is still a challenge to identify and incorporate certain bioactive components capable of replicating those stimuli typical of breast milk that can program growth, infant development and maturation of the immune system. The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life. In addition, considering that the quality of feeding at these early ages will program (Early programming) the health and physiology of the child and the future adult, the study wants to obtain evidence of the effects of this new infant formula on the immune system and the development of the child compared to breast milk during the first year of life, hoping that it promotes proper growth, adequate cognitive development and maturation of the immune system as similar as possible to children fed to the mother's breast.

Conditions

• Infant Growth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Enriched infant formula	Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
DIETARY_SUPPLEMENT	Standard formula	Infants receiving a standard infant formula.
DIETARY_SUPPLEMENT	Breastfeeding arm	Infants exclusively or predominantly breastfed (\>75%).

Timeline

• Start date: 2020-03-02
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-03-12
• Last updated: 2020-12-17

Locations

1 site across 1 country: Spain