Microbiota as Potential Target for Food Allergy

NCT ID: NCT02087930

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cow Milk Allergy

Study Groups

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Cow milk allergy children

Children affected by Immunoglobulin E medited cow milk allergy

No interventions assigned to this group

healthy control

healthy infants

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Berni Canani

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Roberto Berni Canani

Role: primary

0817462680

Other Identifiers

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02/14

Identifier Type: -

Identifier Source: org_study_id

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