ClinicalTrials.gov record NCT05681975

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jan 12, 2023, about 3 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 80 years old
SexAll
LocationSpain
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational, cross-sectional study measures food-specific IgG4 and IgE antibody levels in people reporting symptoms linked to adverse reactions to foods. Each participant gives a very small capillary whole blood sample (about 50 μL) that is analyzed with immunoassay kits. The study gathers these measurements at a single time point.

What it is studying. The study is testing the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody reactions in a population with symptoms associated with adverse reactions to foodstuffs.

What the researchers hope to learn. To determine and describe food-specific IgG4 and IgE antibody reaction levels in people with symptoms related to adverse reactions to foods.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactions

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

  • Antibiotic treatment

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would provide a small capillary (finger‑prick) blood sample (about 50 µL). The sample is analyzed for food‑specific Immunoglobulin G4 (IgG4) and Immunoglobulin E (IgE) antibody reactions using immunoassay kits. The record does not list other procedures, visits, or follow‑up details.

How the study is structured. An observational, cross-sectional (single-visit) study. Participants provide a single small capillary blood sample (50 μL). Samples are tested using immunoassay kits (NutriSMART® and Fastcheckpoc20®) to measure food-specific IgG4 and IgE. No treatments or interventions are given.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Immunoglobulin E-Mediated Food Allergy; Immunoglobulin G4-Related Disease; Symptoms and Signs; Adverse Reaction to Food. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Spain. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 1, 2017
Primary completion
October 2027 (estimated)
Study completion
December 2027 (estimated)
Target enrollment
200 participants (estimated)
Last updated on registry
Jan 12, 2023
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Universidad Politecnica de Madrid
Principal investigator
Lisset Pantoja Arevalo, Food Engineer, Master of Food Engineering applied to health
Universidad Politecnica de Madrid

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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