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Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy

Not Applicable
Recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Gastrointestinal tolerance of experimental formula during at home consumption periodduring 7 days

by evaluating gastrointestinal symptoms, using information recorded by parents daily in a diary

Safety of experimental formula during the at-home consumptionduring 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

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Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie
🇩🇪Berlin, Germany
Birgit Kalb, MD
Contact
birgit.kalb@charite.de

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