Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

NCT ID: NCT05259826

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2025-01-31

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.

Detailed Description

Food intolerances (FI) show an increasing prevalence and represent a particular challenge in clinical practice. The symptoms of a predominantly gastrointestinally mediated food allergy (FA) are similar to the symptoms of other FI (e.g. carbohydrate malabsorption, gluten sensitivity, histamine intolerance, irritable bowel syndrome), so that diagnosis is difficult and often delayed.

Well-evaluated methods for the clarification of an allergic disease are serological screening (IgE against food products or other cross-reacting allergens) and skin prick tests. However, these methodes have their limitations in the diagnosis of seronegative or mainly gastrointestinal-mediated FI. Patients often associate the consumption of certain foods with the clinical symptoms, which often leads to strict self-imposed elimination diets, but rarely to the correct identification of the triggering food.

In a pilot study, the investigators showed that patients with gastrointestinal FI have elevated mucosal IgE levels and TNF using homogenates from intestinal biopsies. Another patient subgroup could be identified that showed low allergic parameters (low mucosal IgE, low TNF) but high mucosal interferon levels, indicating a non-specific inflammation.

In this study, mucosal IgE, tryptase, histamine, IL4, and inflammatory parameters (e.g. TNF, IFN) from different areas of the gastrointestinal tract will be determined in a larger collective. Furthermore, organoids are cultured in vitro from duodenal tissue samples, incubated with blood cells and stimulated with food allergens. The titres of specific IgE from the mucosal homogenates will be correlated with serum levels and organoid stimulation results to identify relevant biomarkers. Microbiome and metabolome analyses will provide information about the intestinal flora in FI.

Conditions

Food Allergy; Food Hypersensitivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

patients with food hypersensitivity

Group Type: EXPERIMENTAL

biopsy sampling

Intervention Type: 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

Group Type: EXPERIMENTAL

biopsy sampling

Intervention Type: 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.

Interventions

biopsy sampling

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• informed consent
• patients with suspected food allergy or hypersensitivity
• healthy controls with indications for endoscopic diagnostics, e.g. tumour history within the family, exclusion of gastritis

Exclusion Criteria

• pregnant person

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

yurdagül zopf

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Erlangen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Yurdagül Zopf, Prof

Role: CONTACT

yurdaguel.zopf@uk-erlangen.de

+4991318545218

Walburga Dieterich, Dr

Role: CONTACT

walburga.dieterich@uk-erlangen.de

+4991318535128

Facility Contacts

Yurdaguel Zopf, Prof

Role: primary

yurdaguel.zopf@uk-erlangen.de

49 9131 8545218

Other Identifiers

21-474-B

Identifier Type: -

Identifier Source: org_study_id