Observatory on Cow's Milk Protein Allergy

Recruiting

• Conditions: Food Allergy
• Interventions: Other: Pepticate® Syneo®

• Registration Number: NCT06085118
• Lead Sponsor: Nutricia Nutrition Clinique

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Status Verified: 2024-06
• Study Start: 2024-06-17
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2031-11
• Study Completion: 2031-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Infants up to and including 8 months (up to 8 months and 29 days).
• Initial diagnosis of allergy to cow proteins, suspected (clinical presumption) or confirmed.
• Prescription of the substitution formula Pepticate® Syneo, according to the doctor's judgement, whether the child is under mixed or weaned breastfeeding.
• Authorisation from a legal representative for the child to take part in the observatory and to collect personal information about the child and the family.
• Membership of the social security system.

Exclusion Criteria

• Infants who have already received partial or total replacement infant formula (regardless of the type of infant formula).
• Contraindication to the use of symbiotics (short small intestine, parenteral nutrition, post-pyloric feeding, central venous catheter) due to the use of Pepticate® Syneo®.
• Diagnosis of severe cow protein allergy requiring an infant amino acid formula from the outset.
• The child's legal guardian is protected (under legal protection, or deprived of liberty by judicial or administrative decision).
• The legal representative is unable to understand the study protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient	Pepticate® Syneo®	Infants up to and including 8 months of age (up to 8 months and 29 days), treated for a suspected or confirmed cow protein allergy.

Primary Outcome Measures

Name	Time	Method
Number and proportion of symptoms	5 years	Numbers and proportion of symptoms (cutaneous, gastrointestinal, respiratory...), and their evolution according to the different forms of cow protein allergy: immediate Immunoglobulin E mediated, delayed non-Immunoglobulin E mediated or mixed and acute food protein-induced enterocolitis syndrome.

Trial Locations

Locations (2)

Cabinet du Dr Phu My TRAN; 🇫🇷 Nice, France

Hôpital Trousseau - APHP; 🇫🇷 Paris, France