Observatory on Cow's Milk Protein Allergy

NCT ID: NCT06085118

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2031-11-30

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.

Conditions

Food Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient

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.

Pepticate® Syneo®

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Maximum Eligible Age: 8 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia Nutrition Clinique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cabinet du Dr Phu My TRAN

Nice, , France

Site Status: RECRUITING

Hôpital Trousseau - APHP

Paris, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Line JOUANNIC

Role: CONTACT

line.samier@danone.com

603883762 ext. +33

Facility Contacts

Phu My TRAN, MD

Role: primary

492040274 ext. +33

Anaïs LEMOINE, MD

Role: primary

Other Identifiers

2023-A01285-40

Identifier Type: -

Identifier Source: org_study_id