Microbiota as Potential Target for Food Allergy (MATFA)

May 24, 2018 updated by: Roberto Berni Canani, Federico II University

Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies 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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Contact:
          • Roberto Berni Canani
          • Phone Number: 0817462680

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Cow milk allergy children
Children affected by Immunoglobulin E medited cow milk allergy
healthy control
healthy infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composition and function gut microbiota in children with cow milk allergy and healthy children
Time Frame: Change from baseline at 6 and 12 months
Change from baseline at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline at 6 and 12 months
Composition and function gut microbiota comparing healthy Italian and healthy children of other countries
Time Frame: Change from baseline at 6 and 12 months
Change from baseline at 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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