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Microbiota as Potential Target for Food Allergy

Study Purpose

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.

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 6 Months - 12 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - children with cow's milk allergy - age 6-12 months

    Exclusion Criteria:

    - concomitant 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 tract - suspected eosinophilic esophagitis or eosinophilic enterocolitis - suspected food-protein-induced enterocolitis syndrome.

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.

Cow Milk Allergy
Arms & Interventions


: Cow milk allergy children

Children affected by Immunoglobulin E medited cow milk allergy

: healthy control

healthy infants


Contact a Trial Team

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International Sites

University of Naples Federico II, Naples, Italy




University of Naples Federico II

Naples, , 80131

Site Contact

Roberto Berni Canani


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