NCT04736082

Safety of an Infant Formula With Hydrolysed Protein in Term Infants

Safety and Suitability of an Infant Formula Manufactured From Extensively Hydrolysed Protein in Healthy Term Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: HiPP GmbH & Co. Vertrieb KG · Industry
• Sex: All
• Age: 0 Days – 25 Days
• Healthy volunteers: Accepted

Summary

A multi-centre, randomised, double-blind, parallel-group, controlled, prospective, non-inferiority intervention clinical trial is performed to assess the safety and suitability of an infant formula manufactured from extensively hydrolysed protein by showing normal growth of healthy term infants during the first 120 days of life with an optional follow up until 180 days of life.

Detailed description

Since many years the use of infant formulae manufactured from hydrolysed proteins are recommended for infants at risk for developing allergies if they cannot be exclusively breast-fed. Although the use of such formulae manufactured from hydrolysed protein is legally authorized according to the respective legal framework since many years (currently: Directive 2006/141/EC), the safety of each hydrolysed protein has to be substantiated by additional clinical data according to new legal requirements (Del. Regulation (EU) 2016/127). This study is intended to generate clinical safety data: demonstrating adequate growth of infants fed a formula manufactured from hydrolysed protein in comparison to infants fed a formula manufactured from intact protein. As formula manufactured from hydrolyzed proteins is known to have beneficial effects on gastrointestinal comfort, it is also fed to infants not at risk for developing allergies. Therefore, this study additionally investigates the impact of hydrolysed protein on gastrointestinal tolerance.

Conditions

• Growth

Interventions

Type	Name	Description
OTHER	Intervention Group: Infant Formula with hydrolyzed protein	Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (intervention formula manufactured from extensively hydrolysed whey protein).
OTHER	Control Group: Infant Formula with intact protein	Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (control formula manufactured from intact cow's milk protein).

Timeline

• Start date: 2021-03-16
• Primary completion: 2021-08-31
• Completion: 2021-10-27
• First posted: 2021-02-03
• Last updated: 2021-11-26

Locations

1 site across 1 country: Germany