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Microbiota as Potential Target for Food Allergy (MATFA)

Primary Purpose

Cow Milk Allergy

Status
Unknown status
Phase
Locations
Italy
Study Type
Observational
Intervention
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Cow Milk Allergy

Eligibility Criteria

6 Months - 12 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • University of Naples Federico IIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Cow milk allergy children

healthy control

Arm Description

Children affected by Immunoglobulin E medited cow milk allergy

healthy infants

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2014
Last Updated
May 24, 2018
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02087930
Brief Title
Microbiota as Potential Target for Food Allergy
Acronym
MATFA
Official Title
Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
Study Type
Observational

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy

7. Study Design

Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cow milk allergy children
Arm Description
Children affected by Immunoglobulin E medited cow milk allergy
Arm Title
healthy control
Arm Description
healthy infants
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Composition and function gut microbiota comparing healthy Italian and healthy children of other countries
Time Frame
Change from baseline at 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
Phone
0817462680

12. IPD Sharing Statement

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Microbiota as Potential Target for Food Allergy

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