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OpenTrials
Completed

NCT Number: NCT04750980

Microbiota and 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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

48 month–84 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food allergy

Other

food allergy

respiratory allergy

Other

respiratory allergy

Healthy controls

Other

healthy controls

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: MATFA I

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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