Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option

Food Allergy Clinical Trial

Official title:

Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072084
• Other study ID #: FAEM
• Status: Completed
• Start date: February 1, 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2022
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Germany	Medical Department 1, University hospital Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes.		Two years