Microbiota and Allergy (MATFA I)

• ClinicalTrials.gov Identifier: NCT04750980
• Recruitment Status: Completed
• First Posted: February 11, 2021
• Last Update Posted: July 27, 2021
• Sponsor: Federico II University
• Information provided by (Responsible Party): Roberto Berni Canani, Federico II University

Study Description

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.

Condition or disease	Intervention/treatment
Allergy	Other: food allergy; Other: respiratory allergy; Other: healthy controls

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: January 30, 2021
• Actual Study Completion Date: January 30, 2021

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Evaluation of gut microbiome features in allergic children and in healthy controls. [ Time Frame: at enrollment ]
   Comparatively evaluation of gut microbiome features in allegic children and in healthy controls.

Secondary Outcome Measures :

1. Gut microbiome and allergy disease course [ Time Frame: at enrollment ]
   Evaluation of gut microbiome influence on allergy disease course
2. Evaluation of gut microbiome features in children affected by different allergies (food and respiratory) [ Time Frame: at enrollment ]
   Comparatively evaluation of gut microbiome features in children with different allergies (food and respiratory)
3. Evaluation of gut microbiome features in children affected by different type of food allergy [ Time Frame: at enrollment ]
   Evaluation of gut microbiome features in children affected by different type of food allergy

Eligibility Criteria

• Ages Eligible for Study: 48 Months to 84 Months (Child)
• Sexes 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

Criteria

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.

Contacts and Locations

Locations

Italy

Department of Traslational Medical Science - University of Naples Federico II

Naples, Italy, 80131

Sponsors and Collaborators

Federico II University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Roberto Berni Canani, Associate Professor, Federico II University
• ClinicalTrials.gov Identifier: NCT04750980
• Other Study ID Numbers: 02e14
• First Posted: February 11, 2021
• Last Update Posted: July 27, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases