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

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

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).

Study Overview

• Status: Completed
• Conditions: Cow's Milk Protein Allergy
• Intervention / Treatment: Other: Experimental formula; Other: Control formula

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie
• Italy
  • Florence, Italy
    • IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini
  • Milan, Italy, 20154
    • Ospedale dei Bambini V. Buzzi Via Castelvetro, 32
  • Naples, Italy
    • Universiy of Naples Federico II
  • Parma, Italy
    • Azienda Ospedaliero Universitaria di Parma, Italy
• Poland
  • Bydgoszcz, Poland
    • Nicolaus Copernicus University in Torun
  • Krakow, Poland
    • Centrum Medyczne Plejady
  • Krakow, Poland
    • Jagiellonian University Medical College
  • Lodz, Poland
    • Wojewodzki Szpital Specjalistyczny im. M. Kopernika
  • Warsaw, Poland, 02-595
    • BioMedical Centers sp. z o.o.
  • Warsaw, Poland
    • Pediatrics Department at the Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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
11. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas
12. Child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the child inappropriate for entry into the study
13. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
14. Child's parents have not reached legal age of majority (18 years).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental 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.	Other: Experimental formula; New hydrolyzed rice protein-based formula; Other: Control formula; Commercially available amino acid-based formula.
Other: Control 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.	Other: Experimental formula; New hydrolyzed rice protein-based formula; Other: Control formula; Commercially available amino acid-based formula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula)	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.	during test day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal tolerance of experimental formula during at home consumption period	by evaluating gastrointestinal symptoms, using information recorded by parents daily in a diary	during 7 days
Safety of experimental formula during the at-home consumption	By assessing the frequency and severity of adverse events reported by parents during the home usage phase	during 7 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Publications and helpful links

General Publications

• Zemrani B, Hays NP, D'Auria E, Mori F, Kalb B, Darwish N, Esposito S, Brzozowska A, Jedynak-Wasowicz U, Beyer K, Szajewska H, Canani RB. Hypoallergenicity of a hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose in children with cow's milk allergy: protocol for a randomized controlled study. The RIGHT-HY study. Front Nutr. 2026 Apr 22;13:1798624. doi: 10.3389/fnut.2026.1798624. eCollection 2026.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 2115INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No