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Trial record 3 of 7 for:    "Cow Milk Allergy" | "Immunoglobulins"

Microbiota as Potential Target for Food Allergy (MATFA)

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ClinicalTrials.gov Identifier: NCT02087930
Recruitment Status : Recruiting
First Posted : March 14, 2014
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, 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.

Condition or disease
Cow Milk Allergy

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Study Type : Observational
Estimated Enrollment : 600 participants
Official Title: Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
Study Start Date : March 2013
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Composition and function gut microbiota comparing healthy Italian and healthy children of other countries [ Time Frame: Change from baseline at 6 and 12 months ]


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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087930


Locations
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Italy
University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani    0817462680      
Sponsors and Collaborators
Federico II University

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Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02087930     History of Changes
Other Study ID Numbers: 02/14
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate