Observing cow's milk protein allergy in infants
Prospective National Observatory for Cow's Milk Protein Allergy.
This study is tracking how cow's milk protein allergy affects infants up to 5 years old who are using a special formula to see how their symptoms change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | N/A to 8 Months |
| Sex | All |
| Sponsor | Nutricia Nutrition Clinique Industry-sponsored |
| Locations | 2 sites (Nice and 1 other locations) |
| Trial ID | NCT06085118 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include infants up to 8 months old with a suspected or confirmed allergy to cow proteins who are prescribed the Pepticate® Syneo® formula.
Not a fit: Patients who have previously received any infant formula or have severe allergies requiring amino acid formulas may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cow's milk protein allergy and improve dietary management for affected infants.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have provided valuable insights into food allergies, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nice and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.