Observatory on Cow's Milk Protein Allergy (OLAF)

Prospective National Observatory for Cow's Milk Protein Allergy.

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.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy
• Intervention / Treatment: Other: Pepticate® Syneo®

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Line JOUANNIC; Phone Number: +33 603883762; Email: line.samier@danone.com

Study Locations

• France
  • Nice, France, 06300
    • Recruiting
    • Cabinet du Dr Phu My TRAN
    • Contact: Phu My TRAN, MD; Phone Number: +33 492040274
  • Paris, France, 75012
    • Not yet recruiting
    • Hôpital Trousseau - APHP
    • Contact: Anaïs LEMOINE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population of our project will be infants up to and including 8 months of age (up to 8 months and 29 days), treated for a suspected or confirmed, newly diagnosed cow protein allergy requiring, according to the investigator's judgement, an initial prescription of the Pepticate® Syneo® advanced cow protein hydrolysate infant formula.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and proportion of symptoms	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.	5 years

Collaborators and Investigators

• Sponsor: Nutricia Nutrition Clinique

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2031

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 2023-A01285-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No