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

Not Applicable

Not yet recruiting

• Conditions: Cow's Milk Protein Allergy
• Interventions: Other: Experimental formula; Other: Control formula

• 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

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2026-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental formula-Control formula	Experimental formula	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.
Experimental formula-Control formula	Control formula	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.
Control formula-Experimental formula	Experimental formula	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.
Control formula-Experimental formula	Control formula	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.

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

Pediatrics Department at the Medical University of Warsaw; 🇵🇱 Warsaw, Poland