Microbiota and Allergy

NCT04750980 | Completed

• 1 other identifier: 02e14
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gut microbiome and allergy disease course

  at enrollment

• Evaluation of gut microbiome features in children affected by different allergies (food and respiratory)

  at enrollment

• Evaluation of gut microbiome features in children affected by different type of food allergy

  at enrollment

Study Arms (3)

Food allergy

Childen with food allergy

Other: food allergy

Respiratory allergy

Children with respiratory allergy

Other: respiratory allergy

Healthy controls

Healthy subjects

Other: healthy controls

Interventions

food allergy OTHER

food allergy

Food allergy

respiratory allergy OTHER

respiratory allergy

Respiratory allergy

healthy controls OTHER

healthy controls

Healthy controls

Eligibility Criteria

• Age: 48 Months - 84 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Children with sure diagnosis of food allergy,
• children with sure diagnosis of respiratory allergy

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 34645820 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: June 1, 2017
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

IT (1)