- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072084
Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bavaria
-
Erlangen, Bavaria, Germany, 91054
- Medical Department 1, University hospital Erlangen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Healthy subjects
|
Patients with food allergy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes.
Time Frame: Two years
|
Two years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martin Raithel, MD, Medical Department 1, University hospital Erlangen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAEM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Food Allergy
-
Vilnius UniversityEnrolling by invitationFood Allergy in Children | Food Allergy in InfantsLithuania
-
Vilnius UniversityEnrolling by invitationFood Allergy in Children | Food Allergy in InfantsLithuania
-
Chinese University of Hong KongRecruiting
-
Assistance Publique Hopitaux De MarseilleUnknown
-
King's College LondonKing's College Hospital NHS Trust; University College London Hospitals; Cambridge... and other collaboratorsRecruitingEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustUnknownEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
University Hospital, MontpellierUnknownFood Allergy Suspected | Food Allergy ProvedFrance
-
Stanford UniversityRecruitingFood Allergy | Food Allergy in ChildrenUnited States
-
Rhode Island HospitalCompletedFood Allergy in Children
-
Rhode Island HospitalVirtually Better, Inc.CompletedFood Allergy in Children