Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Erlangen-Nürnberg Medical School.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01072084
First received: February 18, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 18, 2010
February 18, 2010
February 2010
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option
Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Both study groups will be acquired from the ambulant gastrointestinal consultation of the Medical department 1 of the Universityhospital Erlangen.

Food Allergy
Not Provided
  • Patients with food allergy
  • Healthy subjects
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. Epub 2007 Jan 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
Yes
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
 
NCT01072084
FAEM
No
Dr. med. Yurdagül Zopf, Medical Department 1, University Erlangen
University of Erlangen-Nürnberg Medical School
Not Provided
Principal Investigator: Martin Raithel, MD Medical Department 1, University hospital Erlangen
University of Erlangen-Nürnberg Medical School
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP