Allergy MilkSINEALLIINCT03909113
Tolerability of Hypoallergenic Formula in Children With Cow's Milk Allergy
A study testing amino acid based formula in people with Allergy Milk, run by Federico II University at 1 site in Italy.
Trial summary
Cow's milk protein allergy is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of prevalence of cow's milk protein allergy vary from… Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Allergy Milk
- What is being tested?
- amino acid based formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 31 May 2020
- 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 1 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Consecutive patients aged 1-36 months with diagnosis of Immunoglobulin E-mediated cow milk allergy in the last 12 weeks,
- full and stable remission of allergy symptoms
- Written informed consent form collected by the parents.
Who cannot join
- Infant aged <1 months and >36 months,
- breast fed infants,
- other food allergies,
- other allergic diseases,
- evidence of non-IgE-mediated CMA,
- history of severe anaphylactic reaction,
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- eosinophilic disorders of the gastrointestinal tract,
- chronic systemic diseases,
- congenital cardiac defects,
- active tuberculosis,
- autoimmune diseases,
- immunodeficiency,
- chronic inflammatory bowel diseases,
- celiac disease,
- cystic fibrosis,
- metabolic diseases,
- malignancy,
- chronic pulmonary diseases,
- malformations of the gastrointestinal and/or respiratory tract,
- use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
- investigator's uncertainty about the willingness or ability of the subject 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability of the New Hypoallergenic Formula in Children With IgE Mediated Cow's Milk Allergy
Cow's milk protein allergy is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's milk protein allergy prevalence is often due to differences in study populations, study design and a lack of defined diagnostic criteria. The importance of defined diagnostic criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids delay in diagnosis, which can lead to malnutrition. The treatment of cow's milk protein allergy is the dietary elimination of cow's milk proteins. In non-breastfed infants and children less than 2 years of age, a substitute formula is mandatory as prescribed by several international scientific societies. Extensively hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is often a whey or casein based formula in which the protein has been chopped up in smaller pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant should be maintained on an elimination diet until the child is between 9-12 months of age or at least for 6 months, whichever occurs first. In most cases, symptoms will improve substantially within 2-4 weeks if diagnosis is correct. According to consensus in literature, a therapeutic formula is a formula tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants. The primary study outcome will be the evaluation of the hypoallergenicity of a new aminoacid based formula in children with confirmed immunoglobulin (Ig)E- mediated CMA. According to the American Academy of Pediatrics (AAP) Subcommittee on Nutrition and Allergic Diseases a hypoallergenic formula must be tested in infants and children with hypersensitivity to cow's milk proteins, with findings verified by elimination-challenge tests under double-blind, placebo-controlled conditions (DBPCFC).
- Conditions
- Allergy Milk
- Being tested
- amino acid based 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.
amino acid based formulaDietary supplement
amino acid based formula
| Study group | Role | What they receive |
|---|---|---|
| amino acid based formula | Experimental | amino acid based formula Receives: Dietary Supplement: amino acid based formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects tolerants to a new hypoallergenic formula demonstrated by oral food challenge with the new study formula
All subjects perform an oral food challenge with the new study formula. If the infant not react to the new hypoallergenic formula during the oral food challenge, the subjects tolerate this product.
Measured: After one week from the oral food challenge
Secondary outcomes (1)
Evaluation of body weight in children assuming amino acid based formula
In the absence of reaction to the new amino acid based formula, a subgroup of child (n=15) will continue the second part of the study, with an open-label feeding with amino acid based formula for 180 days.
Measured: after 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Mar 2019
- Primary completion30 Apr 2020
- Study completion31 May 2020
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 Allergy MilkStudies 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
- NCT03909113
- Sponsor's protocol ID
- 440/19
- Acronym
- SINEALLII
- Status last verified
- Feb 2024
- First submitted
- 5 Apr 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nocerino R, Di Scala C, Coppola S, Giglio V, Carucci L, Cosenza L, Voto L, Iannicelli AM, Luzzetti A, Berni Canani R. Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy. Ital J Pediatr. 2021 Jul 3;47(1):151. doi: 10.1186/s13052-021-01096-3.
PubMed 34217356
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of the New Hypoallergenic Formula in Children With IgE Mediated Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT03909113
- Acronym / sponsor ID
- SINEALLII / 440/19
- Conditions
- Allergy Milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 9 Apr 2019 (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 is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's milk protein allergy prevalence is often due to differences in study populations, study design and a lack of defined diagnostic criteria. The importance of defined diagnostic criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids delay in diagnosis, which can lead to malnutrition. The treatment of cow's milk protein allergy is the dietary elimination of cow's milk proteins. In non-breastfed infants and children less than 2 years of age, a substitute formula is mandatory as prescribed by several international scientific societies. Extensively hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is often a whey or casein based formula in which the protein has been chopped up in smaller pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant should be maintained on an elimination diet until the child is between 9-12 months of age or at least for 6 months, whichever occurs first. In most cases, symptoms will improve substantially within 2-4 weeks if diagnosis is correct. According to consensus in literature, a therapeutic formula is a formula tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants. The primary study outcome will be the evaluation of the hypoallergenicity of a new aminoacid based formula in children with confirmed immunoglobulin (Ig)E- mediated CMA. According to the American Academy of Pediatrics (AAP) Subcommittee on Nutrition and Allergic Diseases a hypoallergenic formula must be tested in infants and children with hypersensitivity to cow's milk proteins, with findings verified by elimination-challenge tests under double-blind, placebo-controlled conditions (DBPCFC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amino acid based formula | Experimental | Dietary Supplement: amino acid based formulaamino acid based formula |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Consecutive patients aged 1-36 months with diagnosis of Immunoglobulin E-mediated cow milk allergy in the last 12 weeks,
- full and stable remission of allergy symptoms
- Written informed consent form collected by the parents.
Key exclusion criteria (22 listed)
- Infant aged <1 months and >36 months,
- breast fed infants,
- other food allergies,
- other allergic diseases,
- evidence of non-IgE-mediated CMA,
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 |
|---|---|---|
| amino acid based formulaamino acid based formula | Dietary supplement | amino acid based formula |
Primary outcome
Number of subjects tolerants to a new hypoallergenic formula demonstrated by oral food challenge with the new study formula
Time frame: After one week from the oral food challenge
All subjects perform an oral food challenge with the new study formula. If the infant not react to the new hypoallergenic formula during the oral food challenge, the subjects tolerate this product.
1 secondary outcome
Evaluation of body weight in children assuming amino acid based formula
Time frame: after 180 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 22 Feb 2024.
- Derived from this study: PubMed 34217356Nocerino R, Di Scala C, Coppola S, Giglio V, Carucci L, Cosenza L, Voto L, Iannicelli AM, Luzzetti A, Berni Canani R. Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy. Ital J Pediatr. 2021 Jul 3;47(1):151. doi: 10.1186/s13052-021-01096-3.
- 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 amino acid based formula in people with Allergy Milk, 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 3 inclusion and 22 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 22 Feb 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 subjects tolerants to a new hypoallergenic formula demonstrated by oral food challenge with the new study formula (time frame: After one week from the oral food challenge). 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 NCT03909113, 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 22 Feb 2024.