Health TrialsbyHealthPanel

Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

ConditionsFood AllergyFood Hypersensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

pregnant person

Trial design

Design model

Parallel

Treatments tested in this trial

  • biopsy sampling

    Other intervention

    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.

Treatment groups

115 Participants
are divided into 2 treatment groups
Group A: patients with food hypersensitivityExperimental treatment 1 intervention
Group B: healthy controlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determination of mucosal IgE to identify patients with gastrointestinal food allergy

Homogenates of mucosal biopsies will be checked for IgE levels

Time frame
3 years

Secondary outcomes

1

Identification of patients with food hypersensitivity

Homogenates of mucosal biopsies will be checked for inflammatory parameters (TNF, IFN)

Time frame
3 years
2

Correlation of mucosal IgE and inflammatory parameters with data from organoids

Organoids 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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Erlangen-Nürnberg Medical School

Lead sponsor

Source ClinicalTrials.gov
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