NCT06085118 Observatory on Cow's Milk Protein Allergy
| NCT ID | NCT06085118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nutricia Nutrition Clinique |
| Condition | Food Allergy |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2031-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2024-06-17 with a primary completion date of 2031-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06085118 clinical trial?
This trial is open to participants of all sexes, up to 8 Months, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06085118 currently recruiting?
Yes, NCT06085118 is actively recruiting participants. Contact the research team at line.samier@danone.com for enrollment information.
Where is the NCT06085118 trial being conducted?
This trial is being conducted at Nice, France, Paris, France.
Who is sponsoring the NCT06085118 clinical trial?
NCT06085118 is sponsored by Nutricia Nutrition Clinique. The trial plans to enroll 3,000 participants.