Cow's Milk Protein AllergyRIGHT-HYNCT06633289
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
A study testing Experimental formula in people with Cow's Milk Protein Allergy, run by Société des Produits Nestlé (SPN) at 11 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 days to 3 years
- Conditions the study is for
- Cow's Milk Protein Allergy
- What is being tested?
- Experimental formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 5 Nov 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 days to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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).
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Poland6 sites
Nicolaus Copernicus University in Torun
Bydgoszcz
Centrum Medyczne Plejady
Krakow
Jagiellonian University Medical College
Krakow
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz
BioMedical Centers sp. z o.o.
Warsaw, 02-595
Pediatrics Department at the Medical University of Warsaw
Warsaw
Italy4 sites
IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini
Florence
Ospedale dei Bambini V. Buzzi Via Castelvetro, 32
Milan, 20154
Universiy of Naples Federico II
Naples
Azienda Ospedaliero Universitaria di Parma, Italy
Parma
Germany1 site
Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie
Berlin
About this study
Official title: 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).
- Conditions
- Cow's Milk Protein Allergy
- Being tested
- Experimental formula, Control formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental formulaOther
New hydrolyzed rice protein-based formula
Control formulaOther
Commercially available amino acid-based formula.
| Study group | Role | What they receive |
|---|---|---|
| Experimental formula-Control formula | Other | 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. Receives: Other: Experimental formula; Other: Control formula |
| Control formula-Experimental formula | Other | 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. Receives: Other: Experimental formula; Other: Control formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during test day
Secondary outcomes (2)
Gastrointestinal tolerance of experimental formula during at home consumption period
by evaluating gastrointestinal symptoms, using information recorded by parents daily in a diary
Measured: 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
Measured: during 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start5 Nov 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cow's Milk Protein AllergyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633289
- Sponsor's protocol ID
- 2115INF
- Acronym
- RIGHT-HY
- Status last verified
- May 2026
- First submitted
- 7 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42099766
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
- ClinicalTrials.gov ID
- NCT06633289
- Acronym / sponsor ID
- RIGHT-HY / 2115INF
- Conditions
- Cow's Milk Protein Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental formula-Control formula | Other | Other: Experimental formula, Other: Control formulaBlinded 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 | Other | Other: Experimental formula, Other: Control formulaBlinded 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. |
Who may qualify
- Ages
- 60 days to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental formulaNew hydrolyzed rice protein-based formula | Other | Control formula-Experimental formula, Experimental formula-Control formula |
| Control formulaCommercially available amino acid-based formula. | Other | Control formula-Experimental formula, Experimental formula-Control formula |
Primary outcome
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula)
Time frame: 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.
2 secondary outcomes
Gastrointestinal tolerance of experimental formula during at home consumption period
Time frame: during 7 days
Safety of experimental formula during the at-home consumption
Time frame: during 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 42099766Zemrani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental formula in people with Cow's Milk Protein Allergy, run by Société des Produits Nestlé (SPN) at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula) (time frame: during test day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06633289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.