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Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

Primary Purpose

Food Allergy, Food Hypersensitivity

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
biopsy sampling
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Food Allergy focused on measuring mucosal IgE, inflammation parameter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients with food hypersensitivity

healthy controls

Arm Description

Outcomes

Primary Outcome Measures

Determination of mucosal IgE to identify patients with gastrointestinal food allergy
Homogenates of mucosal biopsies will be checked for IgE levels

Secondary Outcome Measures

Identification of patients with food hypersensitivity
Homogenates of mucosal biopsies will be checked for inflammatory parameters (TNF, IFN)
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

Full Information

First Posted
February 18, 2022
Last Updated
March 11, 2022
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05259826
Brief Title
Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity
Official Title
Improving the Diagnosis of Food Allergy and Food Intolerance by Determining Mucosal IgE and Inflammatory Markers and Validating With Intestinal in Vitro Organoids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Food Hypersensitivity
Keywords
mucosal IgE, inflammation parameter

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Data derived from patients with food hypersensitivity will be compared with data of healthy controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with food hypersensitivity
Arm Type
Experimental
Arm Title
healthy controls
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
biopsy sampling
Intervention Description
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 Outcome Measure Information:
Title
Determination of mucosal IgE to identify patients with gastrointestinal food allergy
Description
Homogenates of mucosal biopsies will be checked for IgE levels
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Identification of patients with food hypersensitivity
Description
Homogenates of mucosal biopsies will be checked for inflammatory parameters (TNF, IFN)
Time Frame
3 years
Title
Correlation of mucosal IgE and inflammatory parameters with data from organoids
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdagül Zopf, Prof
Phone
+4991318545218
Email
yurdaguel.zopf@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Walburga Dieterich, Dr
Phone
+4991318535128
Email
walburga.dieterich@uk-erlangen.de
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof
Phone
49 9131 8545218
Email
yurdaguel.zopf@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

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