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Completed

NCT Number: NCT02087930

Microbiota as Potential Target for Food Allergy

Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora 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. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.

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Key information

Conditions

Cow Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children with cow's milk allergy
  • age 6-12 months

Exclusion criteria

  • concomitant chronic systemic diseases
  • congenital cardiac defects
  • active tuberculosis
  • autoimmune diseases
  • immunodeficiency
  • chronic inflammatory bowel diseases
  • celiac disease, cystic fibrosis
  • metabolic diseases
  • malignancy
  • chronic pulmonary diseases
  • malformations of the gastrointestinal tract
  • suspected eosinophilic esophagitis or eosinophilic enterocolitis
  • suspected food-protein-induced enterocolitis syndrome.

Treatment and study plan

Primary outcomes

  1. Composition and function gut microbiota in children with cow milk allergy and healthy children

    Time frame: Change from baseline at 6 and 12 months

Secondary outcomes

  1. Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries

    Time frame: Change from baseline at 6 and 12 months

  2. Composition and function gut microbiota comparing healthy Italian and healthy children of other countries

    Time frame: Change from baseline at 6 and 12 months

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2014
Registry last updated
Sep 2, 2026

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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