Microbiota as Potential Target for Food Allergy
- Conditions
- Cow Milk Allergy
- Registration Number
- NCT02087930
- Lead Sponsor
- Federico II University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composition and function gut microbiota in children with cow milk allergy and healthy children Change from baseline at 6 and 12 months
- Secondary Outcome Measures
Name Time Method Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries Change from baseline at 6 and 12 months Composition and function gut microbiota comparing healthy Italian and healthy children of other countries Change from baseline at 6 and 12 months
Trial Locations
- Locations (1)
University of Naples Federico II
🇮🇹Naples, Italy