Cow's Milk AllergyHYPO STORYNCT05731206
Hypoallergenicity of a Hydrolyzed Protein Infant Formula
A study testing Hydrolyzed protein infant formula and commercially available hypoallergenic infant formula in people with Cow's Milk Allergy, run by Nutricia Research at 1 site in Italy.
Trial summary
Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy. Read more about this study
- Who is it for?
- Ages 0 days to 3 years
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Hydrolyzed protein infant formula and commercially available hypoallergenic infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2024to 31 Mar 2027
- 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 0 days to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children aged up to 3 years.
- Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:
- Physician-supervised double-blind oral food challenge; or
- Physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or
- Report of convincing allergic reaction to cow's milk or a milk-containing food product, in conjunction with presence of milk-specific serum Immunoglobuline E (IgE) level > 0.7 kilounit per liter (U/L) or by skin prick test (wheal size ≥ 3mm).
- Willing to switch to a different hypoallergenic formula
Show all 9Show fewer
- On elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1).
- Expected minimal consumption of 144ml of test product/day during the open challenge.
- Written informed consent provided by parents/guardians, according to local law.
Who cannot join
- Infants/children who are more suitable to use AAF as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using eHF) or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
- Diagnosis or known allergy to any of the ingredients in the test product.
- Congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions.
- (Twin / triplet) sibling of an infant/child already participating in the study.
- Investigator's uncertainty about the willingness or ability of the subject and his/her parents to comply with the protocol requirements.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Employees and/or children/family members or relatives of employees of Nutricia Research or the participating study sites.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy
Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.
Read the detailed description
The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.
- Conditions
- Cow's Milk Allergy
- Being tested
- Hydrolyzed protein infant formula, commercially available hypoallergenic infant formula
- Keywords
- Infant formula, Hypoallergenicity
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed protein infant formulaOther
Hydrolyzed protein infant formula
commercially available hypoallergenic infant formulaOther
commercially available hypoallergenic infant formula
| Study group | Role | What they receive |
|---|---|---|
| hydrolized protein formula | Experimental | hydrolysed protein formula Receives: Other: Hydrolyzed protein infant formula |
| Control formula | Placebo comparator | commercially available hypoallergenic infant formula Receives: Other: commercially available hypoallergenic infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoallergenicity
The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.
Measured: 25-35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start31 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Why it stopped: Internal discussions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe 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
- Model description
- Crossover assignment and an observational, single-arm, follow-up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731206
- Sponsor's protocol ID
- SBB22R&40330
- Acronym
- HYPO STORY
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT05731206
- Acronym / sponsor ID
- HYPO STORY / SBB22R&40330
- Conditions
- Cow's Milk Allergy
- Keywords
- Infant formula, Hypoallergenicity
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Internal discussions
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Feb 2023 (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.
Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.
Detailed description
The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover assignment and an observational, single-arm, follow-up.
| Arm | Type | Receives |
|---|---|---|
| hydrolized protein formula | Experimental | Other: Hydrolyzed protein infant formulahydrolysed protein formula |
| Control formula | Placebo comparator | Other: commercially available hypoallergenic infant formulacommercially available hypoallergenic infant formula |
Who may qualify
- Ages
- 0 days to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Infants and children aged up to 3 years.
- Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:
- Willing to switch to a different hypoallergenic formula
- On elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1).
- Expected minimal consumption of 144ml of test product/day during the open challenge.
Key exclusion criteria (7 listed)
- Infants/children who are more suitable to use AAF as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using eHF) or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
- Diagnosis or known allergy to any of the ingredients in the test product.
- Congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions.
- (Twin / triplet) sibling of an infant/child already participating in the study.
- Investigator's uncertainty about the willingness or ability of the subject and his/her parents to comply with the protocol requirements.
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 |
|---|---|---|
| Hydrolyzed protein infant formulaHydrolyzed protein infant formula | Other | hydrolized protein formula |
| commercially available hypoallergenic infant formulacommercially available hypoallergenic infant formula | Other | Control formula |
Primary outcome
Hypoallergenicity
Time frame: 25-35 days
The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed protein infant formula and commercially available hypoallergenic infant formula in people with Cow's Milk Allergy, run by Nutricia Research 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 9 inclusion and 7 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: paused, as of the sponsor's last update on 8 May 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 (time frame: 25-35 days). 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 8 May 2024.