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RECRUITINGNA

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

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

NCT06633289•Société des Produits Nestlé (SPN)

View on ClinicalTrials.gov

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).

Eligibility

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
•2. Child gestational age ≥ 37 completed weeks
•3. Child aged ≥ 60 days and less than 36 months at enrollment
•4. Documented IgE-mediated CMPA no more than 6 months prior to enrollment
•5. Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
•6. Child's parent(s) and LAR (if applicable) is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol

Exclusion Criteria

•1. Child is exclusively breastfed
•2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
•3. Congenital heart disease or treatment by B-blockers
•4. Major gastrointestinal disease / abnormalities (other than CMPA)
•5. Known or suspected soy allergy
•6. Glucose-galactose malabsorption
•7. Immunodeficiency
•8. Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment
•9. Persistent wheeze or chronic respiratory disease
•10. Severe uncontrolled eczema or urticaria
+4 more criteria

Locations (11)

Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie

Berlin, Germany

IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini

Florence, 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

Centrum Medyczne Plejady

Krakow, Poland

Jagiellonian University Medical College

Krakow, Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Lodz, Poland

BioMedical Centers sp. z o.o.

Warsaw, Poland

Key Dates

Start Date

November 5, 2024

Primary Completion Date

September 1, 2026

Completion Date

October 1, 2026

Last Updated

July 1, 2025

Enrollment

ESTIMATED participants

Conditions

Cow's Milk Protein Allergy

Interventions

Experimental formula

OTHER

Control formula

OTHER

Contacts

Julia Mauger

CONTACT

(+41) 79 201 9835 julia.mauger@rdls.nestle.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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