Skip to content

Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

Improving the Diagnosis of Food Allergy and Food Intolerance by Determining Mucosal IgE and Inflammatory Markers and Validating With Intestinal in Vitro Organoids

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05259826
Enrollment
115
Registered
2022-03-02
Start date
2022-02-01
Completion date
2025-01-31
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy, Food Hypersensitivity

Keywords

mucosal IgE, inflammation parameter

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.

Interventions

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.

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of mucosal IgE to identify patients with gastrointestinal food allergy3 yearsHomogenates of mucosal biopsies will be checked for IgE levels

Secondary

MeasureTime frameDescription
Identification of patients with food hypersensitivity3 yearsHomogenates of mucosal biopsies will be checked for inflammatory parameters (TNF, IFN)
Correlation of mucosal IgE and inflammatory parameters with data from organoids3 yearsOrganoids are isolated from intestinal biopsies, co-cultured with blood cells and stimulated with food antigens. Gene and protein expression will be correlated with mucosal IgE and inflammation

Countries

Germany

Contacts

Primary ContactYurdagül Zopf, Prof
yurdaguel.zopf@uk-erlangen.de+4991318545218
Backup ContactWalburga Dieterich, Dr
walburga.dieterich@uk-erlangen.de+4991318535128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026