Microbiota and Allergy

Study Overview
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Brief Summary
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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.

Official Title
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Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy

Conditions
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Allergy

Intervention / Treatment
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* Other: food allergy
* Other: respiratory allergy
* Other: healthy controls


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 84 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Food allergy<br>Childen with food allergy | Other: food allergy<br>* food allergy<br>|
| Respiratory allergy<br>Children with respiratory allergy | Other: respiratory allergy<br>* respiratory allergy<br>|
| Healthy controls<br>Healthy subjects | Other: healthy controls<br>* healthy controls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome and allergy disease course | Evaluation of gut microbiome influence on allergy disease course | 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) | 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 | at enrollment |