Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

NCT05259826 | Recruiting

• 1 other identifier: 21-474-B
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to improve the diagnosis of food allergy and hypersensitivity. Intestinal homogenates will be used to determine total IgE, specific IgE, tryptase, histamine and inflammation parameters (IFNgamma, TNFalpha). These data will be correlated with serum values and disease status. In addition, organoids from duodenal tissue will be isolated and cultured in vitro and stimulated with the major food allergens. The gene and protein expression will be checked to identify relevant biomarkers.

Conditions

Food Allergy; Food Hypersensitivity

Keywords

mucosal IgE; inflammation parameter

Outcome Measures

Primary Outcomes (1)

• Determination of mucosal IgE to identify patients with gastrointestinal food allergy

  Homogenates of mucosal biopsies will be checked for IgE levels

  3 years

Secondary Outcomes (2)

• Identification of patients with food hypersensitivity

  3 years

• Correlation of mucosal IgE and inflammatory parameters with data from organoids

  3 years

Study Arms (2)

patients with food hypersensitivity

EXPERIMENTAL

Other: biopsy sampling

healthy controls

EXPERIMENTAL

Other: biopsy sampling

Interventions

biopsy sampling OTHER

1. Biopsies are homogenised in buffer and used for the determination of mucosal IgE and inflammatory parameters. 2. Biopsies are used to isolate organoids, stimulate them with blood cells and food antigens and to study gene and protein expression.

healthy controls; patients with food hypersensitivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• patients with suspected food allergy or hypersensitivity

You may not qualify if:

• pregnant person

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, 91052, Germany

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Chorionic Villi Sampling

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Yurdagül Zopf, Prof

CONTACT

+4991318545218; yurdaguel.zopf@uk-erlangen.de

Walburga Dieterich, Dr

CONTACT

+4991318535128; walburga.dieterich@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Model Details: Data derived from patients with food hypersensitivity will be compared with data of healthy controls

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: February 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)