Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06085118
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
8 Months
Study:
NCT06085118
Study Brief:
Protocol Section:
NCT06085118