Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
RIGHT-HY
1 other identifier
interventional
67
3 countries
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2024
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedStudy Start
First participant enrolled
November 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
July 1, 2025
June 1, 2025
1.8 years
October 7, 2024
June 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Gastrointestinal tolerance of experimental formula during at home consumption period
during 7 days
Safety of experimental formula during the at-home consumption
during 7 days
Study Arms (2)
Experimental formula-Control formula
OTHERBlinded 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
OTHERBlinded 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.
Interventions
New hydrolyzed rice protein-based formula
Commercially available amino acid-based formula.
Eligibility Criteria
You may qualify if:
- 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
- Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
- 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
You may not qualify if:
- 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)
- Known or suspected soy allergy
- Glucose-galactose malabsorption
- Immunodeficiency
- 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
- Persistent wheeze or chronic respiratory disease
- Severe uncontrolled eczema or urticaria
- Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas
- 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
- Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
- Child's parents have not reached legal age of majority (18 years).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 20154, 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, 02-595, Poland
Pediatrics Department at the Medical University of Warsaw
Warsaw, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2024
First Posted
October 9, 2024
Study Start
November 5, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share