Microbiota as Potential Target for Food Allergy

Cow Milk Allergy Clinical Trial

— MATFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02087930
• Other study ID #: 02/14
• Status: Recruiting
• Start date: March 2013
• Est. completion date: September 2020

Study information

• Verified date: May 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow Milk Allergy
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composition and function gut microbiota in children with cow milk allergy and healthy children		Change from baseline at 6 and 12 months
Secondary	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
Secondary	Composition and function gut microbiota comparing healthy Italian and healthy children of other countries		Change from baseline at 6 and 12 months