AllergyNIQANCT06134466
Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy
A study testing Liquid Extensively hydrolyzed cow's milk protein infant formula in people with Allergy and Cow's Milk Allergy, run by Federico II University at 1 site in Italy.
Trial summary
Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to cow's milk proteins. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Cow's Milk Allergy
- What is being tested?
- Liquid Extensively hydrolyzed cow's milk protein infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2024to 22 Jul 2024
- 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants and children between 6 and 36 months of age
- Gestational age ≥ 37 weeks
- Diagnosis of 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 four weeks prior to study enrollment
- Observing a strict cow's milk elimination diet for at least 4 weeks prior to study enrollment and until the completion of the study
- Parent(s) or legal guardian agrees not to enroll infant or child in another interventional clinical study while participating in this study
- Written informed consent obtained from at least one parent (or legally acceptable representative [LAR], if applicable)
- Infant or child's parent(s) / LAR 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
- History of anaphylaxis to milk
- Infant is exclusively breastfed
- Any chronic diseases (except mild-moderate atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
- Major gastrointestinal disease/abnormalities (other than CMA).
- Other allergies.
- Immunodeficiency.
Show all 12Show fewer
- Antihistamine use (excluding eye drops) within 7 days prior to the food challenge or oral steroid use within 14 days prior to the food challenge.
- Persistent wheeze or chronic respiratory disease.
- Severe uncontrolled eczema.
- Infant or child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the infant or child inappropriate for entry into the study.
- Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
- Use of systemic immunomodulatory treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, 80131
About this study
Official title: Hypoallergenicity of a New Extensively Hydrolyzed Casein-based Liquid Formula in Infants and Children With Cow's Milk Allergy (CMA): a Randomized Study
Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to cow's milk proteins. Estimates of CMA prevalence depend on the diagnosis procedure used; recently, a meta-analysis stated an overall pooled estimate for 0-1 year old infants of point prevalence of CMA reported by parents of 4.2% (95 % confidence interval (CI): 3.2-5.4), decreasing to 2.0% (1.5-2.5) when CMA was proven with a double-blind placebo-controlled food challenge (DBPCFC).
CMA manifests through diverse and non-specific symptoms, rendering the CMA diagnosis very difficult. CMA symptoms mainly concern the cutaneous area, the respiratory and gastrointestinal tracts but can also be general. The DBPCFC is therefore considered as the gold standard for the CMA diagnosis.
Read more
CMA management consists in the elimination of any source of non-hydrolyzed cow' milk protein from the diet, which is mainly achieved in children by using extensively hydrolyzed formulae (eHFs). As the molecular weight profile of a given hydrolysate cannot predict potential reaction in a given child, the American Academy of Pediatrics recommended that tolerance/hypoallergenicity of any formula intended for children with CMA should be clinically tested in that specific population.
The purpose of this study is to demonstrate the hypoallergenicity of a new liquid hydrolyzed casein-based formula (Investigational Formula) in the management of infants and children with CMA.
Read the detailed description
This study is a randomized, double-blind, controlled, crossover study that will be performed at a tertiary center for pediatric allergy: the Pediatric Allergy Program of the Department of Translational Medical Science of the University Federico II of Naples, Italy.
In this single-center study, the hypoallergenicity of an investigational extensively hydrolyzed (EH) cow milk protein formula in infants and children with CMA will be prospectively assessed through a doubleblind placebo-controlled food challenge (DBPCFC), with the placebo control and the investigational formula fed in a randomized order.
The design of the food challenges will be based on the approach used to diagnose food allergies: the DBPCFC. Although participants will not be exposed to any CMP in this study, and thus the concept of a "food challenge" does not apply, the general approach of a DBPCFC is still appropriate because it allows systematic, controlled, and standardized assessment of the hypoallergenicity of the Investigational Formula. The number of participants needed to project with 95% confidence (one-sided interval) that less than 10% of infants and children will react to the product is 29 consecutive participants if no clinical reactions are observed. A formula can be labelled hypoallergenic if infants with documented CMA do not react with defined symptoms to the formula under double-blind placebo controlled conditions as described above.
A 7-day home feeding period with the investigational formula will follow. Participants will be monitored for any indication of allergic or other types of adverse events throughout the study.
- Conditions
- Allergy, Cow's Milk Allergy
- Being tested
- Liquid Extensively hydrolyzed cow's milk protein infant formula
- Medical subject headings
- Hypersensitivity, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Extensively hydrolyzed cow's milk protein infant formulaDietary supplement
Liquid Investigational Formula (Extensively hydrolyzed cow's milk protein infant formula) 2.8 g protein/100 kcal
| Study group | Role | What they receive |
|---|---|---|
| Liquid Formula | Experimental | Liquid Formula (Extensively hydrolyzed cow's milk protein infant formula) - 2.8 g protein/100 kcal Receives: Dietary Supplement: Liquid Extensively hydrolyzed cow's milk protein infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of IgE-mediated cow's milk allergy subjects with negative of oral food challenge for the new investigational extensively casein formula
Evaluation of the hypoallergenicity (negative oral food challenge) of an new investigational extensively casein formula in infants and children with IgE-mediated CMA
Measured: Through study completion, an average up tp 50 days
Secondary outcomes (1)
adverse events
Medically confirmed adverse events
Measured: Through study completion, an average up tp 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start13 Feb 2024
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134466
- Sponsor's protocol ID
- 27/2023
- Acronym
- NIQA
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoallergenicity of a New Extensively Hydrolyzed Casein-based Liquid Formula in Infants and Children With Cow's Milk Allergy (CMA): a Randomized Study
- ClinicalTrials.gov ID
- NCT06134466
- Acronym / sponsor ID
- NIQA / 27/2023
- Conditions
- Allergy, Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 18 Nov 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.
Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to cow's milk proteins. Estimates of CMA prevalence depend on the diagnosis procedure used; recently, a meta-analysis stated an overall pooled estimate for 0-1 year old infants of point prevalence of CMA reported by parents of 4.2% (95 % confidence interval (CI): 3.2-5.4), decreasing to 2.0% (1.5-2.5) when CMA was proven with a double-blind placebo-controlled food challenge (DBPCFC).
CMA manifests through diverse and non-specific symptoms, rendering the CMA diagnosis very difficult. CMA symptoms mainly concern the cutaneous area, the respiratory and gastrointestinal tracts but can also be general. The DBPCFC is therefore considered as the gold standard for the CMA diagnosis.
CMA management consists in the elimination of any source of non-hydrolyzed cow' milk protein from the diet, which is mainly achieved in children by using extensively hydrolyzed formulae (eHFs). As the molecular weight profile of a given hydrolysate cannot predict potential reaction in a given child, the American Academy of Pediatrics recommended that tolerance/hypoallergenicity of any formula intended for children with CMA should be clinically tested in that specific population.
The purpose of this study is to demonstrate the hypoallergenicity of a new liquid hydrolyzed casein-based formula (Investigational Formula) in the management of infants and children with CMA.
Detailed description
This study is a randomized, double-blind, controlled, crossover study that will be performed at a tertiary center for pediatric allergy: the Pediatric Allergy Program of the Department of Translational Medical Science of the University Federico II of Naples, Italy.
In this single-center study, the hypoallergenicity of an investigational extensively hydrolyzed (EH) cow milk protein formula in infants and children with CMA will be prospectively assessed through a doubleblind placebo-controlled food challenge (DBPCFC), with the placebo control and the investigational formula fed in a randomized order.
The design of the food challenges will be based on the approach used to diagnose food allergies: the DBPCFC. Although participants will not be exposed to any CMP in this study, and thus the concept of a "food challenge" does not apply, the general approach of a DBPCFC is still appropriate because it allows systematic, controlled, and standardized assessment of the hypoallergenicity of the Investigational Formula. The number of participants needed to project with 95% confidence (one-sided interval) that less than 10% of infants and children will react to the product is 29 consecutive participants if no clinical reactions are observed. A formula can be labelled hypoallergenic if infants with documented CMA do not react with defined symptoms to the formula under double-blind placebo controlled conditions as described above.
A 7-day home feeding period with the investigational formula will follow. Participants will be monitored for any indication of allergic or other types of adverse events throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liquid Formula | Experimental | Dietary Supplement: Liquid Extensively hydrolyzed cow's milk protein infant formulaLiquid Formula (Extensively hydrolyzed cow's milk protein infant formula) - 2.8 g protein/100 kcal |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infants and children between 6 and 36 months of age
- Gestational age ≥ 37 weeks
- Diagnosis of 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 four weeks prior to study enrollment
- Observing a strict cow's milk elimination diet for at least 4 weeks prior to study enrollment and until the completion of the study
Key exclusion criteria (12 listed)
- History of anaphylaxis to milk
- Infant is exclusively breastfed
- Any chronic diseases (except mild-moderate atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
- Major gastrointestinal disease/abnormalities (other than CMA).
- Other allergies.
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 |
|---|---|---|
| Liquid Extensively hydrolyzed cow's milk protein infant formulaLiquid Investigational Formula (Extensively hydrolyzed cow's milk protein infant formula) 2.8 g protein/100 kcal | Dietary supplement | Liquid Formula |
Primary outcome
Number of IgE-mediated cow's milk allergy subjects with negative of oral food challenge for the new investigational extensively casein formula
Time frame: Through study completion, an average up tp 50 days
Evaluation of the hypoallergenicity (negative oral food challenge) of an new investigational extensively casein formula in infants and children with IgE-mediated CMA
1 secondary outcome
adverse events
Time frame: Through study completion, an average up tp 50 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 14 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 Liquid Extensively hydrolyzed cow's milk protein infant formula in people with Allergy and Cow's Milk Allergy, run by Federico II University 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 8 inclusion and 12 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 14 Aug 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. 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?
Number of IgE-mediated cow's milk allergy subjects with negative of oral food challenge for the new investigational extensively casein formula (time frame: Through study completion, an average up tp 50 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 14 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.