Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT01072084
Collaborator
(none)
50
1
10
5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the endoscopic diagnostic options of the endomicroscopy in patients with food intolerance.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Food allergy is with a prevalence of 2-4% a seldom disease. The endoscopy of the gastrointestinal tract and the histological analysis of taken biopsies of the intestinal mucosa are basic instruments in the diagnostic of food allergy. With modern high-resolution video endoscopy the intestinal mucosa can be investigated on inflamed areas and can evaluate several of differential diagnosis. With the implementation of a fluorescein based confocal laser endoscope the intestinal mucosa can be magnified 1000 fold, so that even next to the macroscopic investigation the cellular patterns can be analyzed. The laser endoscope offers for the first time an in vivo presentation of cellular structures. Our study group could utilise for the first time the laser endoscope in patients with colitis ulcerosa for cancer prevention. Hereby, the cancer prediction could be enhanced obviously. Furthermore, we conducted these investigations in more than 1500 patients und could present that this method is a safety method.

    Based on these investigations we want to implement now the laser endoscope in the diagnostic field of food allergy. Patient wit food allergy generates through the intestinal mediators and histamine secretion an oedema, an increase of inflammatory cells, vasodilatation and expansion of lymph nodes. In comparison of patients with food allergy to healthy subjects, the degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes will be evaluated.

    The aim of the present study is to detect these cellular structures in patients with food allergy and to open with that a new diagnostic option in patient with an allergy disease.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option
    Actual Study Start Date :
    Feb 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with food allergy

    Healthy subjects

    Outcome Measures

    Primary Outcome Measures

    1. The degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes. [Two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • new diagnosed and not treated patients with food allergy
    Exclusion Criteria:
    • decreased clotting (Quick < 50%, platelet < 50.000/µl)

    • not given consent

    • known allergy against fluorescein

    • pregnant and breastfeeding woman

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Department 1, University hospital Erlangen Erlangen Bavaria Germany 91054

    Sponsors and Collaborators

    • University of Erlangen-Nürnberg Medical School

    Investigators

    • Principal Investigator: Martin Raithel, MD, Medical Department 1, University hospital Erlangen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    yurdagül zopf, Professor Dr., University of Erlangen-Nürnberg Medical School
    ClinicalTrials.gov Identifier:
    NCT01072084
    Other Study ID Numbers:
    • FAEM
    First Posted:
    Feb 19, 2010
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by yurdagül zopf, Professor Dr., University of Erlangen-Nürnberg Medical School
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2022