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NCT05681975 Clinical Trial

Immunoglobulin G4 and Immunoglobulin E Antibodies in a Population With Adverse Reactions to Foodstuffs-related Symptoms

Symptoms and Signs Clinical Trial

Official title:
Food-specific Immunoglobulin G4 and Immunoglobulin E Antibody Reactions in a Population With Adverse Reactions to Foodstuffs-related Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05681975
Other study ID # 1720IL0389
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date December 2027

Study information
Verified date January 2023
Source Universidad Politecnica de Madrid
Contact Lisset S Pantoja-Arévalo, MSc
Phone +34910677879
Email l.pantoja@upm.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (ARFS). To determine the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody reactions (AbR).

Description:

Volunteers with symptoms related with adverse reactions to foodstuffs (ARFS) and suspicion of having a food allergy or a food intolerance are enrolled in this study. A 50μl of capillary whole blood is analyzed and the levels of food-specific immunoglobulin G4 (IgG4) or immunoglobulin E (IgE) antibody reactions (AbR) are determined.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2027
Est. primary completion date October 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adults (>18 years of age) - To present symptoms related to adverse reactions to foodstuffs (ARFS) Exclusion Criteria: - Antibiotic treatment

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactions
Immunoassay kits (NutriSMART® and Fastcheckpoc20® In-Vitro Diagnostic kits, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms.

Locations
Country Name City State
Spain Universidad Politécnica de Madrid Madrid

Sponsors (1)
Lead Sponsor Collaborator
Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Food-specific Immunoglobulin G4 antibody reactions Immunoassay kits (NutriSMART® In-Vitro Diagnostic kit, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms. 0 days
Secondary Food-specific Immunoglobulin E antibody reactions Immunoassay kits (Fastcheckpoc20® In-Vitro Diagnostic kit, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms. 0 days
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