Observing cow's milk protein allergy in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to track the symptoms and progression of cow's milk protein allergy in infants up to 5 years old who have been diagnosed with this condition. It focuses on those prescribed the Pepticate® Syneo® formula, an advanced protein hydrolyzate intended for special medical purposes. The study will recruit participants from both community practices and hospitals across France, collecting data on their health outcomes over time. By following a cohort of newly diagnosed infants, the study seeks to provide valuable insights into the management of this allergy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cabinet du Dr Phu My TRAN
  Nice, France Recruiting
• Hôpital Trousseau - APHP
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Line JOUANNIC
• Email: line.samier@danone.com
• Phone: 603883762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.