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NCT Number: NCT05259826

Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Erlangen, 91052, Germany

Location status: Recruiting

Location contact

Yurdaguel Zopf, Prof

CONTACT

[email protected]

49 9131 8545218

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biopsy sampling

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

Primary outcomes

  1. Determination of mucosal IgE to identify patients with gastrointestinal food allergy

    Time frame: 3 years

    Homogenates of mucosal biopsies will be checked for IgE levels

Secondary outcomes

  1. Identification of patients with food hypersensitivity

    Time frame: 3 years

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

  2. Correlation of mucosal IgE and inflammatory parameters with data from organoids

    Time frame: 3 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Walburga Dieterich, Dr

CONTACT

[email protected]

+4991318535128

Yurdagül Zopf, Prof

CONTACT

[email protected]

+4991318545218

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2022
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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