Recruiting

RIGHT-HYHypoallergenic Rice Protein Formula for Infants with Cow's Milk Allergy

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What is being tested

Experimental formula

+ Control formula

Other
Who is being recruted

Food Hypersensitivity+2

+ Hypersensitivity

+ Hypersensitivity, Immediate

+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorSociété des Produits Nestlé (SPN)
Study ContactJulia Mauger
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 5, 2024

Actual date on which the first participant was enrolled.

This study is focused on infants and young children who have a specific type of allergy known as Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA). The main goal is to find out if a new formula made from hydrolyzed rice protein is less likely to cause allergic reactions in these children. This is important because children with this type of allergy often struggle to find safe and nutritious food options, and a hypoallergenic formula could provide a much-needed alternative. Participants in the study will receive the new formula to see if it causes any allergic reactions. Researchers will monitor the children's reactions to determine if the formula is truly hypoallergenic. The study does not mention specific risks or benefits, but the main focus is ensuring the formula is safe and does not trigger allergies. The findings could lead to a new option for children with cow's milk protein allergies, improving their nutrition and quality of life.

Official TitleHypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
NCT06633289
Principal SponsorSociété des Produits Nestlé (SPN)
Study ContactJulia Mauger
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

67 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Food HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System DiseasesMilk Hypersensitivity

Criteria

6 inclusion criteria required to participate
Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable)
Child gestational age ≥ 37 completed weeks
Child aged ≥ 60 days and less than 36 months at enrollment
Documented IgE-mediated CMPA no more than 6 months prior to enrollment
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14 exclusion criteria prevent from participating
Child is exclusively breastfed
Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
Congenital heart disease or treatment by B-blockers
Major gastrointestinal disease / abnormalities (other than CMPA)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Blinded cross-over oral food challenge sequence starting by Control followed by Experimental formula. Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.

Group II

Blinded cross-over oral food challenge sequence starting by Experimental formula followed by Control. Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Recruiting

Universiy of Naples Federico II

Naples, ItalyOpen Universiy of Naples Federico II in Google Maps
Recruiting soon

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

Berlin, Germany
Recruiting soon

IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini

Florence, Italy
Recruiting soon

Ospedale dei Bambini V. Buzzi Via Castelvetro, 32

Milan, Italy
Recruiting
11 Study Centers