NCT06633250

Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.

Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 8 Months
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).

Conditions

• Cow Milk Protein Allergy

Interventions

Type	Name	Description
OTHER	Test Formula	Hydrolyzed rice protein formula
OTHER	Control Formula	Commercially available extensively hydrolyzed cow's milk formula

Timeline

• Start date: 2024-10-25
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-10-09
• Last updated: 2025-12-26

Locations

19 sites across 3 countries: Germany, Italy, Poland