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NCT Number: NCT06085118

Observatory on 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.

Recruiting

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Key information

Age range

Up to 8 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet du Dr Phu My TRAN, Nice, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pepticate® Syneo®

Other

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

Primary outcomes

  1. Number and proportion of symptoms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Line JOUANNIC

CONTACT

[email protected]

603883762 ext. +33

Sponsors and collaborators

Lead sponsor

Nutricia Nutrition Clinique

Industry

Registry information

Official study title

Prospective National Observatory for Cow's Milk Protein Allergy.

Acronym: OLAF

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Oct 16, 2023
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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