NCT06085118

Observatory on Cow's Milk Protein Allergy

Prospective National Observatory for Cow's Milk Protein Allergy.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Nutricia Nutrition Clinique · Industry
• Sex: All
• Age: 8 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed. The Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.

Detailed description

This is a prospective, observational, descriptive, longitudinal, multicentric study aimed at describing a cohort of infants with a recently suspected or confirmed allergy to cow's milk protein, who were treated in outpatient and inpatient settings. The recruitment of patients eligible for this observatory will be done via community medicine (private practices of pediatricians and general practitioners) as well as in hospitals throughout France.

Conditions

• Food Allergy

Interventions

Type	Name	Description
OTHER	Pepticate® Syneo®	Introduction of the nutritional treatment Pepticate® Syneo® (high protein hydrolysate), as a foodstuff for special medical purposes (product already available on the market).

Timeline

• Start date: 2024-06-17
• Primary completion: 2031-11-01
• Completion: 2031-11-01
• First posted: 2023-10-16
• Last updated: 2024-06-25

Locations

2 sites across 1 country: France