Allergy MilkATMAIINCT03861910
Dietary Choice for the Management of Cow's Milk Allergy Influences Other Allergic Manifestations
An observational study of Allergy Milk and Allergy;Food, run by Federico II University at 1 site in Italy.
Trial summary
Food allergy is a common chronic condition in childhood. Recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Allergy Milk, Allergy;Food, Allergic Asthma
- What is being tested?
- hypoallergenic formulas
- How many people
- 365 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Dec 2021
- Phase
- Observational
- 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 12 months
- All sexes
- Child
Study population: Children who were consecutively observed at a FP office because the recent occurrence of signs and symptoms possibly related to IgE-mediated CMA were sent to our tertiary centre for paediatric allergy for possible inclusion in the study. Only subjects who met the inclusion criteria will be invited to participate to the study.Written informed consent will be obtained from the parents of each subject. Anamnestic, demographic, anthropometric and clinical data, as well as information on socio-demographic factors, family and living conditions, parental history of allergic diseases, maternal smoking during pregnancy, environmental tobacco smoke exposure, number of siblings, and pet ownership were obtained from the parents and recorded in a clinical database. For children with sure diagnosis of IgE-mediated CMA during a 3-year follow-up,3 visits every 12 months will be performed. Stool samples for metagenomics and metabolomics and blood sample for epigenetics studies will be collected.
Who may be able to join
- age 1-12 months
- IgE-mediated CMA
Who cannot join
- cow's milk protein-induced anaphylaxis,
- food protein induced enterocolitis syndrome,
- other food allergies,
- other allergic diseases,
- non-CMA-related atopic eczema,
- eosinophilic disorders of the gastrointestinal tract,
Show all 19Show fewer
- 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,
- administration of prebiotics or probiotics during the 4 weeks before enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Choice for the Management of Cow's Milk Allergy Influences the Acquisition of Oral Tolerance and the Occurrence of Other Allergic Manifestations
Food allergy is a common chronic condition in childhood. Recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. The increased food allergy prevalence in children has an important economic impact, with significant direct costs for the healthcare system and even larger costs for the families of food-allergic patients. In addition, children with food allergies are at increased risk to develop other allergic manifestations later in life. According to a recent study, children with a food allergy are 2 to 4 times more likely to develop other atopic manifestations such as asthma (4.0 times), atopic eczema (2.4 times), and respiratory allergies (3.6 times), compared to children without a food allergy. Cow's milk allergy is among the most common food allergy in early childhood, with an estimated prevalence of 2% to 3%. It has been previously showed that in children with cow milk allergy, an extensively hydrolysed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG induced higher tolerance rates compared to extensively hydrolysed casein formula without Lactobacillus rhamnosus GG and other formulas. These findings were consistent with those of a 1-year follow-up study performed in the US that showed better outcomes using an extensively hydrolysed casein formula+Lactobacillus rhamnosus GG vs. an extensively hydrolysed casein formula or amino acid-based formula for the first-line dietary management of cow milk allergy. In addition it has been recently demonstrated that extensively hydrolysed casein formula + Lactobacillus rhamnosus GG reduces the incidence of other atopic manifestations and hastens the development of oral tolerance in children with IgE-mediated cow milk allergy.
The present randomized controlled trial (RCT) was designed to test whether different dietary interventions could influence the occurrence of other atopic manifestations in children with IgE-mediated cow milk allergy.
- Being tested
- hypoallergenic formulas
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoallergenic formulasDietary supplement
hypoallergenic formulas used for cow milk allergy treatment
| Study group | Role | What they receive |
|---|---|---|
| extensively hydrolyzed casein formula+LGG | subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG as exclusion diet Receives: Dietary Supplement: hypoallergenic formulas | |
| extensively hydrolyzed whey formula; | subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed whey formula as exclusion diet Receives: Dietary Supplement: hypoallergenic formulas | |
| hydrolyzed rice formula | subjects with IgE mediated cow milk allergy treated with hydrolyzed rice formula as exclusion diet Receives: Dietary Supplement: hypoallergenic formulas | |
| soy based formula | subjects with IgE mediated cow milk allergy treated with soy based formula as exclusion diet Receives: Dietary Supplement: hypoallergenic formulas | |
| amino-acid based formula | subjects with IgE mediated cow milk allergy treated with amino-acid based formula as exclusion diet Receives: Dietary Supplement: hypoallergenic formulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subjects with occurrence of other of allergic manifestations
To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy
Measured: 3 years
Secondary outcomes (7)
Rate of subjects with tolerance acquisition to cow's milk
To evaluate the tolerance acquisition to cow's milk
Measured: 3 years
Change in metagenomics and metabolomics
16S rRNA gene amplicon sequencing
Measured: 3 years
Epigenetic modifications in cytokines genes
Serum levels (pg/ml) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy
Measured: 3 years
Epigenetic modifications in cytokines genes
Methylation rate (%) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergyFOXP3 in children with cow's milk allergy
Measured: 3 years
Rate of subjects with occurrence of other of allergic manifestations
To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy
Measured: after 4 to 6 years follow-up
Rate of subjects with tolerance acquisition to cow's milk
To evaluate the tolerance acquisition to cow's milk
Measured: after 4 to 6 years follow-up
Rate of subjects with any autoimmune disease
To evaluate the occurrence of type 1 diabetes, celiac disease, juvenile idiopathic arthritis, thyroiditis, inflammatory bowel diseases
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study startDec 2014
- Primary completionMay 2020
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 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
- NCT03861910
- Sponsor's protocol ID
- 109n19
- Acronym
- ATMAII
- Status last verified
- Jun 2024
- First submitted
- 21 Feb 2019
- Last updated
- 26 Jun 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Choice for the Management of Cow's Milk Allergy Influences the Acquisition of Oral Tolerance and the Occurrence of Other Allergic Manifestations
- ClinicalTrials.gov ID
- NCT03861910
- Acronym / sponsor ID
- ATMAII / 109n19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 4 Mar 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.
Food allergy is a common chronic condition in childhood. Recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. The increased food allergy prevalence in children has an important economic impact, with significant direct costs for the healthcare system and even larger costs for the families of food-allergic patients. In addition, children with food allergies are at increased risk to develop other allergic manifestations later in life. According to a recent study, children with a food allergy are 2 to 4 times more likely to develop other atopic manifestations such as asthma (4.0 times), atopic eczema (2.4 times), and respiratory allergies (3.6 times), compared to children without a food allergy. Cow's milk allergy is among the most common food allergy in early childhood, with an estimated prevalence of 2% to 3%. It has been previously showed that in children with cow milk allergy, an extensively hydrolysed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG induced higher tolerance rates compared to extensively hydrolysed casein formula without Lactobacillus rhamnosus GG and other formulas. These findings were consistent with those of a 1-year follow-up study performed in the US that showed better outcomes using an extensively hydrolysed casein formula+Lactobacillus rhamnosus GG vs. an extensively hydrolysed casein formula or amino acid-based formula for the first-line dietary management of cow milk allergy. In addition it has been recently demonstrated that extensively hydrolysed casein formula + Lactobacillus rhamnosus GG reduces the incidence of other atopic manifestations and hastens the development of oral tolerance in children with IgE-mediated cow milk allergy.
The present randomized controlled trial (RCT) was designed to test whether different dietary interventions could influence the occurrence of other atopic manifestations in children with IgE-mediated cow milk allergy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| extensively hydrolyzed casein formula+LGG | – | Dietary Supplement: hypoallergenic formulassubjects with IgE mediated cow milk allergy treated with extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG as exclusion diet |
| extensively hydrolyzed whey formula; | – | Dietary Supplement: hypoallergenic formulassubjects with IgE mediated cow milk allergy treated with extensively hydrolyzed whey formula as exclusion diet |
| hydrolyzed rice formula | – | Dietary Supplement: hypoallergenic formulassubjects with IgE mediated cow milk allergy treated with hydrolyzed rice formula as exclusion diet |
| soy based formula | – | Dietary Supplement: hypoallergenic formulassubjects with IgE mediated cow milk allergy treated with soy based formula as exclusion diet |
| amino-acid based formula | – | Dietary Supplement: hypoallergenic formulassubjects with IgE mediated cow milk allergy treated with amino-acid based formula as exclusion diet |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Children who were consecutively observed at a FP office because the recent occurrence of signs and symptoms possibly related to IgE-mediated CMA were sent to our tertiary centre for paediatric allergy for possible inclusion in the study. Only subjects who met the inclusion criteria will be invited to participate to the study.Written informed consent will be obtained from the parents of each subject. Anamnestic, demographic, anthropometric and clinical data, as well as information on socio-demographic factors, family and living conditions, parental history of allergic diseases, maternal smoking during pregnancy, environmental tobacco smoke exposure, number of siblings, and pet ownership were obtained from the parents and recorded in a clinical database. For children with sure diagnosis of IgE-mediated CMA during a 3-year follow-up,3 visits every 12 months will be performed. Stool samples for metagenomics and metabolomics and blood sample for epigenetics studies will be collected.
Key inclusion criteria (2 listed)
- age 1-12 months
- IgE-mediated CMA
Key exclusion criteria (19 listed)
- cow's milk protein-induced anaphylaxis,
- food protein induced enterocolitis syndrome,
- other food allergies,
- other allergic diseases,
- non-CMA-related atopic eczema,
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 |
|---|---|---|
| hypoallergenic formulashypoallergenic formulas used for cow milk allergy treatment | Dietary supplement | amino-acid based formula, extensively hydrolyzed casein formula+LGG, extensively hydrolyzed whey formula;, hydrolyzed rice formula, soy based formula |
Primary outcome
Rate of subjects with occurrence of other of allergic manifestations
Time frame: 3 years
To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy
7 secondary outcomes
Rate of subjects with tolerance acquisition to cow's milk
Time frame: 3 years
Change in metagenomics and metabolomics
Time frame: 3 years
Epigenetic modifications in cytokines genes
Time frame: 3 years
Epigenetic modifications in cytokines genes
Time frame: 3 years
Rate of subjects with occurrence of other of allergic manifestations
Time frame: after 4 to 6 years follow-up
Rate of subjects with tolerance acquisition to cow's milk
Time frame: after 4 to 6 years follow-up
Rate of subjects with any autoimmune disease
Time frame: 6 years
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 26 Jun 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?
An observational study of Allergy Milk and Allergy;Food, 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 2 inclusion and 19 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 26 Jun 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?
Rate of subjects with occurrence of other of allergic manifestations (time frame: 3 years). 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 26 Jun 2024.