Food Allergy Clinical Trial
— OLAFOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | November 2031 |
Est. primary completion date | November 2031 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 8 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Trousseau - APHP | Paris |
Lead Sponsor | Collaborator |
---|---|
Nutricia Nutrition Clinique |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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