Improving food allergy diagnosis using mucosal IgE levels
Improving the Diagnosis of Food Allergy and Food Intolerance by Determining Mucosal IgE and Inflammatory Markers and Validating With Intestinal in Vitro Organoids
This study is testing a new way to diagnose food allergies by looking at specific markers in gut tissue to see if it helps people get better answers about their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT05259826 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the diagnosis of food allergies and hypersensitivities by analyzing mucosal IgE levels and other inflammatory parameters from intestinal biopsies. Researchers will correlate these findings with serum values and disease status, while also culturing organoids from duodenal tissue to identify relevant biomarkers in response to major food allergens. The study addresses the challenges of diagnosing gastrointestinal-mediated food allergies, which often present similar symptoms to other food intolerances. By utilizing advanced techniques, the study seeks to provide a more accurate diagnostic approach for affected patients.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected food allergies or hypersensitivities and healthy controls requiring endoscopic diagnostics.
Not a fit: Patients who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of food allergies, reducing the reliance on elimination diets and improving patient outcomes.
How similar studies have performed: Previous pilot studies have shown promising results in identifying mucosal IgE levels as a potential diagnostic marker for food intolerances, indicating a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erlangen
- Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg — Erlangen, Germany (Recruiting)
Study contacts
- Study coordinator: Yurdagül Zopf, Prof
- Email: yurdaguel.zopf@uk-erlangen.de
- Phone: +4991318545218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.