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
  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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • 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
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072084

Contacts
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

Locations
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   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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 September 18, 2014