Clinical trial NCT01072084: Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option
Official title: Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: food allergy
confocal laser endoscope
diagnosis
Diagnosis of food allergy
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both study groups will be acquired from the ambulant gastrointestinal consultation of the Medical department 1 of the Universityhospital Erlangen.

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

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 criteria: 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

Primary outcomes:
measure: The degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Medical Department 1, University hospital Erlangen
state: Bavaria
Study officials:
affiliation: Medical Department 1, University hospital Erlangen
name: Martin Raithel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. doi: 10.1053/j.gastro.2007.01.048. Epub 2007 Jan 31.