IgE-Mediated Cow Milk AllergyNCT07197814
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
A study testing Rice formula (New formula based on hydrolysed rice proteins) in people with IgE-Mediated Cow Milk Allergy, run by Health and Happiness Research Limited at 1 site in Italy.
Trial summary
The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy. In case the Rice formula is well tolerated, the formula will be considered " hypoallergenic ". Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- IgE-Mediated Cow Milk Allergy
- What is being tested?
- Rice formula (New formula based on hydrolysed rice proteins)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and young children between 1 and 36 months of age
- Consuming at least 240 ml/day of formula
- Gestational age ≥ 37 weeks
- Diagnosis of IgE-mediated CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment
- Stable clinical condition and free from any symptoms possibly related to CMA for at least ≥4 weeks prior to recruitment
- Observing a strict cow's milk proteins elimination diet for at least 4 weeks prior to study enrollment
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- Parents or legal guardians agree not to enroll infant in another interventional clinical study while participating in this study
- Written informed consent form obtained from both parents (or legally acceptable representative [LAR], if applicable)
- Infant's parents / LAR are 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.
- Signed authorization obtained from both parents or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period
Who cannot join
- Infant is exclusively breastfed.
- Any chronic diseases, chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
- Major gastrointestinal disease/abnormalities (other than CMA).
- Other food allergies
- Eosinophilic disorders of the gastrointestinal tract.
- Evidence of non-IgE-mediated CMA.
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- Immunodeficiency.
- Use of drugs that may interfere with the interpretation and safety of the SPT procedure planned on Inclusion visit such as antihistamines and topical corticosteroids in the previous week, angiotensin-converting enzyme (ACE) inhibitors within the 2 days before or beta-blockers the day before as well as skin moisturizers used on the skin where solution drops will be applied.
- Previous use of systemic immunomodulatory treatment at any time before study entry.
- Use of systemic antibiotics or anti-mycotic drugs within 4 weeks before study entry.
- Persistent wheeze or chronic respiratory disease.
- Severe uncontrolled eczema.
- Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
- Infant's parents/LAR have medical or psychiatric condition that, in the judgement of the Investigator, would make the subject inappropriate for entry into the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Federico II, University of Naples, Department of Translational Medical Science
Naples
Roberto Berni Canani, Professor, 0039 0817462680, berni@unina.it
Roberto Berni Canani, Professor
About this study
Official title: Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins in Children With IgE-mediated Cow's Milk Allergy
The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy. In case the Rice formula is well tolerated, the formula will be considered " hypoallergenic ".
The main question it aims to answer is: Does the Rice formula cause allergic reactions in infants and young children who are allergic to cow's milk? Researchers will compare during a double-blind placebo-controlled food challenge (DBPCFC) the Rice formula to a Placebo formula to see if any allergic symptom appears after feeding with the Rice formula. If children do not show any allergic symptoms during the DBPCFC, they will then be exclusively formula-fed the Rice formula for 7 days.
Read more
Participants will:
- come at the hospital twice (around 7 days apart) for the DBPCFC
- then, after this procedure, be fed the Rice formula for 7 days, as a replacement for their usual infant formula
Their parents will pay attention to the appearance of any allergic symptom after each day of the DBPCFC, and during the 7-day feeding period. They will keep a diary of any adverse event in their child, the use of any concomitant treatment, and the introduction in their child's diet of any new allergenic food. In addition, during the 7-day feeding period, they will report quantities of the Rice formula consumed, data on regurgitations/vomiting if any, stool consistency/frequency/colour and their satisfaction.
- Conditions
- IgE-Mediated Cow Milk Allergy
- Being tested
- Rice formula (New formula based on hydrolysed rice proteins), Placebo formula
- Keywords
- Cow's milk allergy, Hydrolyzed rice proteins-based formula, IgE-mediated, Oral food challenge, Hypoallergenicity, Tolerance
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice formula (New formula based on hydrolysed rice proteins)Other
Infant formula based on hydrolysed rice proteins.
Placebo formulaOther
The placebo formula will be the formula the subject is currently successfully fed with as part of his/her diet to eliminate cow's milk proteins.
| Study group | Role | What they receive |
|---|---|---|
| DBPCFC = Day 1: Rice formula; Day 2: Placebo formula | Experimental | On Day 1 of the DBPCFC, subjects will receive the Rice formula. On Day 2 of the DBPCFC, subjects will receive the Placebo formula. If subjects tolerate the Rice formula during this DBPCFC, they will then be fed the Rice formula for 7 days. Receives: Other: Rice formula (New formula based on hydrolysed rice proteins); Other: Placebo formula |
| DBPCFC = Day 1: Placebo formula; Day 2: Rice formula | Experimental | On Day 1 of the DBPCFC, subjects will receive the Placebo formula. On Day 2 of the DBPCFC, subjects will receive the Rice formula. If subjects tolerate the Rice formula during this DBPCFC, they will then be fed the Rice formula for 7 days. Receives: Other: Rice formula (New formula based on hydrolysed rice proteins); Other: Placebo formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoallergenicity of the Rice formula
It will be assessed through the absence of medically confirmed allergic reaction to the study formula (Rice formula), based on assessment of clinical signs and symptoms at clinical DBPCFC testing and during the 7-day open feeding period.
Measured: At the end of the 7-day open feeding period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start23 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgE-Mediated Cow Milk AllergyStudies of the same condition, open and under way.
- 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
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health and Happiness Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federico II University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197814
- Sponsor's protocol ID
- BST-001
- Status last verified
- Nov 2026
- First submitted
- 26 Sep 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins in Children With IgE-mediated Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT07197814
- Acronym / sponsor ID
- BST-001
- Conditions
- IgE-Mediated Cow Milk Allergy
- Keywords
- Cow's milk allergy, Hydrolyzed rice proteins-based formula, IgE-mediated, Oral food challenge, Hypoallergenicity, Tolerance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Health and Happiness Research LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Federico II University
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Sep 2025 (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 goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy. In case the Rice formula is well tolerated, the formula will be considered " hypoallergenic ".
The main question it aims to answer is: Does the Rice formula cause allergic reactions in infants and young children who are allergic to cow's milk? Researchers will compare during a double-blind placebo-controlled food challenge (DBPCFC) the Rice formula to a Placebo formula to see if any allergic symptom appears after feeding with the Rice formula. If children do not show any allergic symptoms during the DBPCFC, they will then be exclusively formula-fed the Rice formula for 7 days.
Participants will:
- come at the hospital twice (around 7 days apart) for the DBPCFC
- then, after this procedure, be fed the Rice formula for 7 days, as a replacement for their usual infant formula
Their parents will pay attention to the appearance of any allergic symptom after each day of the DBPCFC, and during the 7-day feeding period. They will keep a diary of any adverse event in their child, the use of any concomitant treatment, and the introduction in their child's diet of any new allergenic food. In addition, during the 7-day feeding period, they will report quantities of the Rice formula consumed, data on regurgitations/vomiting if any, stool consistency/frequency/colour and their satisfaction.
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 |
|---|---|---|
| DBPCFC = Day 1: Rice formula; Day 2: Placebo formula | Experimental | Other: Rice formula (New formula based on hydrolysed rice proteins), Other: Placebo formulaOn Day 1 of the DBPCFC, subjects will receive the Rice formula. On Day 2 of the DBPCFC, subjects will receive the Placebo formula. If subjects tolerate the Rice formula during this DBPCFC, they will then be fed the Rice formula for 7 days. |
| DBPCFC = Day 1: Placebo formula; Day 2: Rice formula | Experimental | Other: Rice formula (New formula based on hydrolysed rice proteins), Other: Placebo formulaOn Day 1 of the DBPCFC, subjects will receive the Placebo formula. On Day 2 of the DBPCFC, subjects will receive the Rice formula. If subjects tolerate the Rice formula during this DBPCFC, they will then be fed the Rice formula for 7 days. |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Infants and young children between 1 and 36 months of age
- Consuming at least 240 ml/day of formula
- Gestational age ≥ 37 weeks
- Diagnosis of IgE-mediated CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment
- Stable clinical condition and free from any symptoms possibly related to CMA for at least ≥4 weeks prior to recruitment
Key exclusion criteria (14 listed)
- Infant is exclusively breastfed.
- Any chronic diseases, chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
- Major gastrointestinal disease/abnormalities (other than CMA).
- Other food allergies
- Eosinophilic disorders of the gastrointestinal tract.
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 |
|---|---|---|
| Rice formula (New formula based on hydrolysed rice proteins)Infant formula based on hydrolysed rice proteins. | Other | DBPCFC = Day 1: Placebo formula; Day 2: Rice formula, DBPCFC = Day 1: Rice formula; Day 2: Placebo formula |
| Placebo formulaThe placebo formula will be the formula the subject is currently successfully fed with as part of his/her diet to eliminate cow's milk proteins. | Other | DBPCFC = Day 1: Placebo formula; Day 2: Rice formula, DBPCFC = Day 1: Rice formula; Day 2: Placebo formula |
Primary outcome
Hypoallergenicity of the Rice formula
Time frame: At the end of the 7-day open feeding period
It will be assessed through the absence of medically confirmed allergic reaction to the study formula (Rice formula), based on assessment of clinical signs and symptoms at clinical DBPCFC testing and during the 7-day open feeding period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
Federico II, University of Naples, Department of Translational Medical Science
Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice formula (New formula based on hydrolysed rice proteins) in people with IgE-Mediated Cow Milk Allergy, run by Health and Happiness Research Limited at 1 site in Italy.
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 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoallergenicity of the Rice formula (time frame: At the end of the 7-day open feeding period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.