Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
- Conditions
- Cow's Milk Protein Allergy
- Registration Number
- NCT06633289
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 67
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula) during test day by measuring the proportion of participants who "passed" the food challenge test, meaning who consumed all doses and exhibited no allergic reactions to any of the doses of the experimental formula.
- Secondary Outcome Measures
Name Time Method Gastrointestinal tolerance of experimental formula during at home consumption period during 7 days by evaluating gastrointestinal symptoms, using information recorded by parents daily in a diary
Safety of experimental formula during the at-home consumption during 7 days By assessing the frequency and severity of adverse events reported by parents during the home usage phase
Trial Locations
- Locations (11)
Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie
🇩🇪Berlin, Germany
IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini
🇮🇹Firenze, Italy
Ospedale dei Bambini V. Buzzi Via Castelvetro, 32
🇮🇹Milan, Italy
Universiy of Naples Federico II
🇮🇹Naples, Italy
Azienda Ospedaliero Universitaria di Parma, Italy
🇮🇹Parma, Italy
Nicolaus Copernicus University in Torun
🇵🇱Bydgoszcz, Poland
Jagiellonian University Medical College
🇵🇱Krakow, Poland
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
🇵🇱Lodz, Poland
BioMedical Centers sp. z o.o.
🇵🇱Warsaw, Poland
Scroll for more (1 remaining)Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie🇩🇪Berlin, GermanyBirgit Kalb, MDContactbirgit.kalb@charite.de