Microbiota as Potential Target for Food Allergy (MATFA)

Federico II University

Status: Unknown

Conditions: Cow Milk Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT02087930

02/14

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 6 to 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

Cow milk allergy children

Description:

Children affected by Immunoglobulin E medited cow milk allergy

healthy control

Description:

healthy infants