Observatory on Cow's Milk Protein Allergy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pepticate® Syneo®.
- Who it may be relevant to
- Registry conditions: Food Allergy. Basic parameters: up to 8 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective National Observatory for Cow's Milk Protein Allergy.
Overview
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.
Interventions
- 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).
Primary outcome measures
- Number and proportion of symptoms [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Cabinet du Dr Phu My TRAN — Nice
- Hôpital Trousseau - APHP — Paris
Identifiers
NCT: NCT06085118 · 2023-A01285-40