Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04750980
Previous Study | Return to List | Next Study

Microbiota and Allergy (MATFA I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04750980
Recruitment Status : Completed
First Posted : February 11, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Brief Summary:
Food allergy derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota 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. Preliminary results of MATFA study demonstrated gut microbiota in allergic children.These findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.

Condition or disease Intervention/treatment
Allergy Other: food allergy Other: respiratory allergy Other: healthy controls

Layout table for study information
Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Food allergy
Childen with food allergy
Other: food allergy
food allergy

Respiratory allergy
Children with respiratory allergy
Other: respiratory allergy
respiratory allergy

Healthy controls
Healthy subjects
Other: healthy controls
healthy controls




Primary Outcome Measures :
  1. Evaluation of gut microbiome features in allergic children and in healthy controls. [ Time Frame: at enrollment ]
    Comparatively evaluation of gut microbiome features in allegic children and in healthy controls.


Secondary Outcome Measures :
  1. Gut microbiome and allergy disease course [ Time Frame: at enrollment ]
    Evaluation of gut microbiome influence on allergy disease course

  2. Evaluation of gut microbiome features in children affected by different allergies (food and respiratory) [ Time Frame: at enrollment ]
    Comparatively evaluation of gut microbiome features in children with different allergies (food and respiratory)

  3. Evaluation of gut microbiome features in children affected by different type of food allergy [ Time Frame: at enrollment ]
    Evaluation of gut microbiome features in children affected by different type of food allergy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   48 Months to 84 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children with food allergy, children with respiratory allergy and health controls aged 48-84 months
Criteria

Inclusion Criteria:

  • Children with sure diagnosis of food allergy,
  • children with sure diagnosis of respiratory allergy

Exclusion Criteria:

  • age at enrollment <48 months or >84 months;
  • eosinophilic disorders of the gastrointestinal tract;
  • chronic systemic diseases;
  • congenital cardiac defects;
  • acute or chronic infections;
  • autoimmune diseases;
  • immunodeficiencies;
  • chronic inflammatory bowel diseases;
  • celiac disease;
  • cystic fibrosis or other forms of primary pancreatic insufficiency;
  • genetic and metabolic diseases;
  • food intolerances;
  • malignancy;
  • chronic pulmonary diseases;
  • malformations of the respiratory tract or of the gastrointestinal tract;
  • pre-, pro- or sinbiotic use in the previous 3 months;
  • antibiotics or gastric acidity inhibitors use in the previous 3 months.

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): NCT04750980


Locations
Layout table for location information
Italy
Department of Traslational Medical Science - University of Naples Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Roberto Berni Canani, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT04750980    
Other Study ID Numbers: 02e14
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Immune System Diseases