NCT06633289

Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy

Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 60 Days – 3 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).

Conditions

• Cow's Milk Protein Allergy

Interventions

Type	Name	Description
OTHER	Experimental formula	New hydrolyzed rice protein-based formula
OTHER	Control formula	Commercially available amino acid-based formula.

Timeline

• Start date: 2024-11-05
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2024-10-09
• Last updated: 2025-07-01

Locations

11 sites across 3 countries: Germany, Italy, Poland