Microbiota and Allergy

Completed

• Conditions: Allergy
• Interventions: Other: food allergy; Other: respiratory allergy; Other: healthy controls

• Registration Number: NCT04750980
• Lead Sponsor: Federico II University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Food allergy	food allergy	Childen with food allergy
Respiratory allergy	respiratory allergy	Children with respiratory allergy
Healthy controls	healthy controls	Healthy subjects

Primary Outcome Measures

Name	Time	Method
Evaluation of gut microbiome features in allergic children and in healthy controls.	at enrollment	Comparatively evaluation of gut microbiome features in allegic children and in healthy controls.

Secondary Outcome Measures

Name	Time	Method
Evaluation of gut microbiome features in children affected by different type of food allergy	at enrollment	Evaluation of gut microbiome features in children affected by different type of food allergy
Gut microbiome and allergy disease course	at enrollment	Evaluation of gut microbiome influence on allergy disease course
Evaluation of gut microbiome features in children affected by different allergies (food and respiratory)	at enrollment	Comparatively evaluation of gut microbiome features in children with different allergies (food and respiratory)

Trial Locations

Locations (1)

Department of Traslational Medical Science - University of Naples Federico II; 🇮🇹 Naples, Italy