Status:
RECRUITING
Observatory on Cow's Milk Protein Allergy
Lead Sponsor:
Nutricia Nutrition Clinique
Conditions:
Food Allergy
Eligibility:
All Genders
Up to 8 years
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...
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 we...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06085118
Start Date
June 17 2024
End Date
November 1 2031
Last Update
June 25 2024
Active Locations (2)
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1
Cabinet du Dr Phu My TRAN
Nice, France, 06300
2
Hôpital Trousseau - APHP
Paris, France, 75012