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

Recruiting

• Conditions: Symptoms and Signs; Adverse Reaction to Food; Immunoglobulin E-Mediated Food Allergy; Immunoglobulin G4-Related Disease

• Registration Number: NCT05681975
• Lead Sponsor: Universidad Politecnica de Madrid

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Last Update Submitted: 2023-01-03
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12
• Primary Completion: 2027-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults (>18 years of age)
• To present symptoms related to adverse reactions to foodstuffs (ARFS)

Exclusion Criteria

• Antibiotic treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Food-specific Immunoglobulin G4 antibody reactions	0 days	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.

Secondary Outcome Measures

Name	Time	Method
Food-specific Immunoglobulin E antibody reactions	0 days	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.

Trial Locations

Locations (1)

Universidad Politécnica de Madrid; 🇪🇸 Madrid, Spain