AllergyMATFA INCT04750980
Microbiota and Allergy
An observational study of Allergy, run by Federico II University at 1 site in Italy.
Trial summary
Food allergy derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota results in an unbalanced local and systemic immune response to food allergens. Read more about this study
- Who is it for?
- Ages 48 to 84 months
- Conditions the study is for
- Allergy
- What is being tested?
- food allergy and respiratory allergy
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 30 Jan 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 48 to 84 months
- All sexes
- Child
Study population: Children with food allergy, children with respiratory allergy and health controls aged 48-84 months
Who may be able to join
- Children with sure diagnosis of food allergy,
- children with sure diagnosis of respiratory allergy
Who cannot join
- age at enrollment <48 months or >84 months;
- eosinophilic disorders of the gastrointestinal tract;
- chronic systemic diseases;
- congenital cardiac defects;
- acute or chronic infections;
- autoimmune diseases;
Show all 17Show fewer
- immunodeficiencies;
- chronic inflammatory bowel diseases;
- celiac disease;
- cystic fibrosis or other forms of primary pancreatic insufficiency;
- genetic and metabolic diseases;
- food intolerances;
- malignancy;
- chronic pulmonary diseases;
- malformations of the respiratory tract or of the gastrointestinal tract;
- pre-, pro- or sinbiotic use in the previous 3 months;
- antibiotics or gastric acidity inhibitors use in the previous 3 months.
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: Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
Food allergy derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota 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. Preliminary results of MATFA study demonstrated gut microbiota in allergic children.These findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.
- Conditions
- Allergy
- Being tested
- food allergy, respiratory allergy, healthy controls
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food allergyOther
food allergy
respiratory allergyOther
respiratory allergy
healthy controlsOther
healthy controls
| Study group | Role | What they receive |
|---|---|---|
| Food allergy | Childen with food allergy Receives: Other: food allergy | |
| Respiratory allergy | Children with respiratory allergy Receives: Other: respiratory allergy | |
| Healthy controls | Healthy subjects Receives: Other: healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of gut microbiome features in allergic children and in healthy controls.
Comparatively evaluation of gut microbiome features in allegic children and in healthy controls.
Measured: at enrollment
Secondary outcomes (3)
Gut microbiome and allergy disease course
Evaluation of gut microbiome influence on allergy disease course
Measured: at enrollment
Evaluation of gut microbiome features in children affected by different allergies (food and respiratory)
Comparatively evaluation of gut microbiome features in children with different allergies (food and respiratory)
Measured: at enrollment
Evaluation of gut microbiome features in children affected by different type of food allergy
Evaluation of gut microbiome features in children affected by different type of food allergy
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Jun 2017
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
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 AllergyStudies of the same condition, open and under way.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750980
- Sponsor's protocol ID
- 02e14
- Acronym
- MATFA I
- Status last verified
- Jul 2021
- First submitted
- 8 Feb 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Filippis F, Paparo L, Nocerino R, Della Gatta G, Carucci L, Russo R, Pasolli E, Ercolini D, Berni Canani R. Specific gut microbiome signatures and the associated pro-inflamatory functions are linked to pediatric allergy and acquisition of immune tolerance. Nat Commun. 2021 Oct 13;12(1):5958. doi: 10.1038/s41467-021-26266-z.
PubMed 34645820
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. 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
- NCT04750980
- Acronym / sponsor ID
- MATFA I / 02e14
- Conditions
- Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 11 Feb 2021 (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 derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota 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. Preliminary results of MATFA study demonstrated gut microbiota in allergic children.These findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food allergy | – | Other: food allergyChilden with food allergy |
| Respiratory allergy | – | Other: respiratory allergyChildren with respiratory allergy |
| Healthy controls | – | Other: healthy controlsHealthy subjects |
Who may qualify
- Ages
- 48 to 84 months
- Sex
- All
- Age groups
- Child
- Study population
- Children with food allergy, children with respiratory allergy and health controls aged 48-84 months
Key inclusion criteria (2 listed)
- Children with sure diagnosis of food allergy,
- children with sure diagnosis of respiratory allergy
Key exclusion criteria (17 listed)
- age at enrollment <48 months or >84 months;
- eosinophilic disorders of the gastrointestinal tract;
- chronic systemic diseases;
- congenital cardiac defects;
- acute or chronic infections;
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 |
|---|---|---|
| food allergyfood allergy | Other | Food allergy |
| respiratory allergyrespiratory allergy | Other | Respiratory allergy |
| healthy controlshealthy controls | Other | Healthy controls |
Primary outcome
Evaluation of gut microbiome features in allergic children and in healthy controls.
Time frame: at enrollment
Comparatively evaluation of gut microbiome features in allegic children and in healthy controls.
3 secondary outcomes
Gut microbiome and allergy disease course
Time frame: at enrollment
Evaluation of gut microbiome features in children affected by different allergies (food and respiratory)
Time frame: at enrollment
Evaluation of gut microbiome features in children affected by different type of food allergy
Time frame: at enrollment
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 27 Jul 2021.
- Derived from this study: PubMed 34645820De Filippis F, Paparo L, Nocerino R, Della Gatta G, Carucci L, Russo R, Pasolli E, Ercolini D, Berni Canani R. Specific gut microbiome signatures and the associated pro-inflamatory functions are linked to pediatric allergy and acquisition of immune tolerance. Nat Commun. 2021 Oct 13;12(1):5958. doi: 10.1038/s41467-021-26266-z.
- 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, 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 17 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 27 Jul 2021. 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?
Evaluation of gut microbiome features in allergic children and in healthy controls. (time frame: at enrollment). 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 NCT04750980, 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 27 Jul 2021.