NCT05731206

Hypoallergenicity of a Hydrolyzed Protein Infant Formula

Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 0 Days – 3 Years
• Healthy volunteers: Not accepted

Summary

Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.

Detailed description

The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.

Conditions

• Cow's Milk Allergy

Interventions

Type	Name	Description
OTHER	Hydrolyzed protein infant formula	Hydrolyzed protein infant formula
OTHER	commercially available hypoallergenic infant formula	commercially available hypoallergenic infant formula

Timeline

• Start date: 2024-07-31
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2023-02-16
• Last updated: 2024-05-08

Locations

1 site across 1 country: Italy