OLAF: Observatory on Cow's Milk Protein Allergy

Nutricia Nutrition Clinique (Industry)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Anticipated Enrollment :
3000 participants
Observational Model:
Time Perspective:
Official Title:
Prospective National Observatory for Cow's Milk Protein Allergy.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2031
Anticipated Study Completion Date :
Nov 1, 2031

Arms and Interventions

Arm Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria


Ages Eligible for Study:
N/A to 8 Months
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Hôpital Trousseau - APHP Paris France 75012

Sponsors and Collaborators

  • Nutricia Nutrition Clinique


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Nutricia Nutrition Clinique
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 2023-A01285-40
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2023