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Trial record 12 of 340 for:    "Food Allergy"

The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy

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ClinicalTrials.gov Identifier: NCT03265262
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children.

Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals.

Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure.

Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population


Condition or disease Intervention/treatment Phase
FOOD ALLERGY Diagnostic Test: The basophil activation test (BAT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Children receiving OFC during a diagnost
paediatric patients attending food allergy
Diagnostic Test: The basophil activation test (BAT)
Single sample: 5 mL of venous blood




Primary Outcome Measures :
  1. BAT positive and negative predictive values as compared with OFC [ Time Frame: 2 years ]
    BAT versus OFC


Secondary Outcome Measures :
  1. BAT quantitative results as compared with the minimal reacting dose for OFC [ Time Frame: 2 years ]
    BAT versus OFC



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 0 - 18 years
  • Attending La Timone Paediatric Hospital for OFC
  • Social insurance
  • Parents and if possible child have received information and signed the consent form

Exclusion Criteria:

  • Patients not receiving an OFC
  • Lack of social insurance
  • Inability to understand the study information
  • Unwilling to participate

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): NCT03265262


Contacts
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Contact: Ania CARSIN 04.91.68.67.65 ania.carsin@ap-hm.fr
Contact: Claire MORANDO claire.morando@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Ania CARSIN       ania.carsin@ap-hm.fr   
Contact: Claire MORANDO       claire.morando@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle Desalbres Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03265262     History of Changes
Other Study ID Numbers: 2017-26
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate