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Recruiting NCT05681975

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

Observational Immunoglobulin E-Mediated Food Allergy Immunoglobulin G4-Related Disease Symptoms and Signs Adverse Reaction to Food

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactions.
Who it may be relevant to
Registry conditions: Immunoglobulin E-Mediated Food Allergy, Immunoglobulin G4-Related Disease, Symptoms and Signs, Adverse Reaction to Food. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Food-specific Immunoglobulin G4 antibody reactions [Time frame: 0 days]
Secondary outcome measures (1)
  • Food-specific Immunoglobulin E antibody reactions [Time frame: 0 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Antibiotic treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Spain · 1 center
  • Universidad Politécnica de Madrid — Madrid

Identifiers

NCT: NCT05681975 · 1720IL0389

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗