Microbiota and Allergy (MATFA I)

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

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.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Other: food allergy; Other: respiratory allergy; Other: healthy controls

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Department of Traslational Medical Science - University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with food allergy, children with respiratory allergy and health controls aged 48-84 months

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls; Healthy subjects	Other: healthy controls; healthy controls
Food allergy; Childen with food allergy	Other: food allergy; food allergy
Respiratory allergy; Children with respiratory allergy	Other: respiratory allergy; respiratory allergy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• De Filippis F, Paparo L, Nocerino R, Della Gatta G, Carucci L, Russo R, Pasolli E, Ercolini D, Berni Canani R. Specific gut microbiome signatures and the associated pro-inflamatory functions are linked to pediatric allergy and acquisition of immune tolerance. Nat Commun. 2021 Oct 13;12(1):5958. doi: 10.1038/s41467-021-26266-z.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 02e14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No