Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option
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Purpose
The purpose of this study is to evaluate the endoscopic diagnostic options of the endomicroscopy in patients with food intolerance.
| Condition |
|---|
|
Food Allergy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option |
- The degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes. [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Patients with food allergy |
| Healthy subjects |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Both study groups will be acquired from the ambulant gastrointestinal consultation of the Medical department 1 of the Universityhospital Erlangen.
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| Contact: Yurdagül Zopf, MD | 0049-9131-85 ext 45071 | yurdaguel.zopf@uk-erlangen.de |
| Contact: Martin Raithel, MD | 0049-9131-85 ext 45006 | martin.raithel@uk-erlangen.de |
| Germany | |
| Medical Department 1, University hospital Erlangen | Not yet recruiting |
| Erlangen, Bavaria, Germany, 91054 | |
| Contact: Yurdagül Zopf, MD 0049-9131-85 ext 45071 yurdagül.zopf@uk-erlangen.de | |
| Contact: Martin Raithel, MD 0049-9131-85 ext 45071 martin.raithel@uk-erlangen.de | |
| Principal Investigator: | Martin Raithel, MD | Medical Department 1, University hospital Erlangen |
More Information
Publications:
| Responsible Party: | Dr. med. Yurdagül Zopf, Medical Department 1, University Erlangen |
| ClinicalTrials.gov Identifier: | NCT01072084 History of Changes |
| Other Study ID Numbers: | FAEM |
| Study First Received: | February 18, 2010 |
| Last Updated: | February 18, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Erlangen-Nürnberg Medical School:
|
food allergy confocal laser endoscope diagnosis Diagnosis of food allergy |
Additional relevant MeSH terms:
|
Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 16, 2013