Observatory on Cow's Milk Protein Allergy
ConditionFood Allergy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 8
SponsorNutricia Nutrition Clinique
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
The target population of our project will be infants up to and including 8 months of age (up to 8 months and 29 days), treated for a suspected or confirmed, newly diagnosed cow protein allergy requiring, according to the investigator's judgement, an initial prescription of the Pepticate® Syneo® advanced cow protein hydrolysate infant formula.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pepticate® Syneo®
Other interventionIntroduction of the nutritional treatment Pepticate® Syneo® (high protein hydrolysate), as a foodstuff for special medical purposes (product already available on the market).
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Patient1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov