Microbiota and Allergy

Allergy Clinical Trial

— MATFA I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750980
• Other study ID #: 02e14
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: July 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Gender: All
• Age group: 48 Months to 84 Months

Eligibility

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.

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity

Intervention

Other:
• food allergy
food allergy
• respiratory allergy
respiratory allergy
• healthy controls
healthy controls

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gut microbiome and allergy disease course	Evaluation of gut microbiome influence on allergy disease course	at enrollment
Secondary	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
Secondary	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