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

January 3, 2023 updated by: Lisset Pantoja Arevalo, Universidad Politecnica de Madrid

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lisset S Pantoja-Arévalo, MSc
  • Phone Number: 77879 +34910677879
  • Email: l.pantoja@upm.es

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Universidad Politécnica de Madrid
        • Contact:
          • Lisset Pantoja-Arévalo, MSc
          • Phone Number: 77879 +34 910677879
          • Email: l.pantoja@upm.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults presenting symptoms related to adverse reactions to foodstuffs and/ or with suspicion of having a food allergy or food intolerance

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Antibiotic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food-specific Immunoglobulin G4 antibody reactions
Time Frame: 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.
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food-specific Immunoglobulin E antibody reactions
Time Frame: 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.
0 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Politecnica de Madrid

Investigators

  • Principal Investigator: Lisset Pantoja-Arévalo, MSc, Universidad Politécnica de Madrid.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Anticipated)

October 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1720IL0389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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