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Microbiota and Allergy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 48 Months - 84 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Federico II University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Arms & Interventions


: Food allergy

Childen with food allergy

: Respiratory allergy

Children with respiratory allergy

: Healthy controls

Healthy subjects


Other: - food allergy

food allergy

Other: - respiratory allergy

respiratory allergy

Other: - healthy controls

healthy controls

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Naples, Italy




Department of Traslational Medical Science - University of Naples Federico II

Naples, , 80131

Site Contact

Roberto Berni Canani, MD, PhD



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