Cow Milk AllergyMATFANCT02087930
Microbiota as Potential Target for Food Allergy
An observational study of Cow Milk Allergy, run by Federico II University at 1 site in Italy.
Trial summary
Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Cow Milk Allergy
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Sep 2020
- 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 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with cow's milk allergy
- age 6-12 months
Who cannot join
- concomitant chronic systemic diseases
- congenital cardiac defects
- active tuberculosis
- autoimmune diseases
- immunodeficiency
- chronic inflammatory bowel diseases
Show all 13Show fewer
- celiac disease, cystic fibrosis
- metabolic diseases
- malignancy
- chronic pulmonary diseases
- malformations of the gastrointestinal tract
- suspected eosinophilic esophagitis or eosinophilic enterocolitis
- suspected food-protein-induced enterocolitis syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.
- Conditions
- Cow Milk Allergy
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cow milk allergy children | Children affected by Immunoglobulin E medited cow milk allergy | |
| healthy control | healthy infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition and function gut microbiota in children with cow milk allergy and healthy children
Measured: Change from baseline at 6 and 12 months
Secondary outcomes (2)
Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries
Measured: Change from baseline at 6 and 12 months
Composition and function gut microbiota comparing healthy Italian and healthy children of other countries
Measured: Change from baseline at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionMay 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 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
- NCT02087930
- Sponsor's protocol ID
- 02/14
- Acronym
- MATFA
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2014
- Last updated
- 2 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
- ClinicalTrials.gov ID
- NCT02087930
- Acronym / sponsor ID
- MATFA / 02/14
- Conditions
- Cow Milk Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 14 Mar 2014 (estimated)
- 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 (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow milk allergy children | – | –Children affected by Immunoglobulin E medited cow milk allergy |
| healthy control | – | –healthy infants |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with cow's milk allergy
- age 6-12 months
Key exclusion criteria (13 listed)
- concomitant chronic systemic diseases
- congenital cardiac defects
- active tuberculosis
- autoimmune diseases
- immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composition and function gut microbiota in children with cow milk allergy and healthy children
Time frame: Change from baseline at 6 and 12 months
2 secondary outcomes
Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries
Time frame: Change from baseline at 6 and 12 months
Composition and function gut microbiota comparing healthy Italian and healthy children of other countries
Time frame: Change from baseline at 6 and 12 months
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 2 Sep 2026.
Related trials for Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
Not yet recruiting
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
Cow's Milk Protein Allergy (CMPA)
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
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 Cow 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 2 inclusion and 13 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 2 Sep 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?
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?
Composition and function gut microbiota in children with cow milk allergy and healthy children (time frame: Change from baseline at 6 and 12 months). 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 2 Sep 2026.