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

• Sponsor: Universidad Politecnica de Madrid (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05681975
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 122
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Immunoglobulin E-Mediated Food Allergy; Immunoglobulin G4-Related Disease; Symptoms and Signs; Adverse Reaction to Food	Diagnostic Test: Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactions

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Food-specific Immunoglobulin G4 and Immunoglobulin E Antibody Reactions in a Population With Adverse Reactions to Foodstuffs-related Symptoms
• Actual Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Oct 1, 2027
• Anticipated Study Completion Date: Dec 1, 2027

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adults (>18 years of age)

• To present symptoms related to adverse reactions to foodstuffs (ARFS)

Exclusion Criteria:

• Antibiotic treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Politécnica de Madrid	Madrid		Spain	28040

Sponsors and Collaborators

• Universidad Politecnica de Madrid

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisset Pantoja Arevalo, Food Engineer, Master of Food Engineering applied to health, Universidad Politecnica de Madrid
• ClinicalTrials.gov Identifier: NCT05681975
• Other Study ID Numbers: 1720IL0389
• First Posted: Jan 12, 2023
• Last Update Posted: Jan 12, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Food Hypersensitivity; Immunoglobulin G4-Related Disease; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Immunoglobulin G

Study Results

No Results Posted as of Jan 12, 2023