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CompletedNCT04750980MATFA IUpdated Jul 27, 2021

Microbiota and Allergy

An observational study in Allergy, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 48 Months to 84 Months. Per ClinicalTrials.gov, last updated 2021-07-27.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
48 Months to 84 Months
Sex
All
01

Study 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. 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.

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Conditions studied

  • Allergy

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03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 120 is close to the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
48 Months to 84 Months
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children with food allergy, children with respiratory allergy and health controls aged 48-84 months

Inclusion criteria

  • Children with sure diagnosis of food allergy,
  • children with sure diagnosis of respiratory allergy

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Food allergy

    Childen with food allergy

    Other: food allergy

  • Respiratory allergy

    Children with respiratory allergy

    Other: respiratory allergy

  • Healthy controls

    Healthy subjects

    Other: healthy controls

Interventions

  • Otherfood allergy

    food allergy

  • Otherrespiratory allergy

    respiratory allergy

  • Otherhealthy controls

    healthy controls

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: at enrollment

Secondary outcomes

  1. Gut microbiome and allergy disease course

    Evaluation of gut microbiome influence on allergy disease course

    Time frame: at enrollment

  2. 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)

    Time frame: at enrollment

  3. 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

    Time frame: at enrollment

07

Study locations

1 site
  • Department of Traslational Medical Science - University of Naples Federico II
    Naples, 80131, Italy
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04750980
Lead sponsor
Federico II University
Responsible party
Roberto Berni Canani (Associate Professor, Federico II University) — Principal investigator
First posted
Feb 11, 2021
Start date
Jun 1, 2017
Primary completion
Jan 30, 2021
Completion
Jan 30, 2021
Last update
Jul 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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