Observatory on Cow's Milk Protein Allergy
Recruiting now
Conditions studied: Food Allergy
In brief
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.
Key facts
- Study ID
- NCT06085118
- Run by
- Nutricia Nutrition Clinique
- People needed
- 3000
- Starts
- 2024-06-17
- Expected to finish
- 2031-11-01
- Last updated by the study team
- 2024-06-25
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cabinet du Dr Phu My TRAN — Nice, France (enrolling)
- Hôpital Trousseau - APHP — Paris, France
Full record on ClinicalTrials.gov
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