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Trial record 14 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Food Hypersensitivity"

Improvement of Foodallergy Diagnostic in Gastrointestinal Tract

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ClinicalTrials.gov Identifier: NCT03151252
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:

Currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal tract are scarce. The endoscopic segmental Lavage is the method of choice, but it´s controversial.

Additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the mucosa cells and biopsies are taken. Comparative to the Lavage specific IgE antibodies, Tumor necrosis factor- alpha, Eosinophilic cation protein and mastcell tryptase were measured.


Condition or disease Intervention/treatment Phase
Food Allergy Diagnostic Test: Cytobrush Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improvement of Foodallergy Diagnostic in Gastrointestinal Tract With a New Kind of Sampling
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Food allergy
Patients with confirmed foodspecific- IgE antibodies in blood
Diagnostic Test: Cytobrush
During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.

healthy controls
participants without foodspecific- IgE antibodies in blood and other gastrointestinal symptoms
Diagnostic Test: Cytobrush
During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.

gastointestinal symptoms without foodallergy in blood
Patients without foodspecific- IgE antibodies in blood, but with gastrointestinal symptoms
Diagnostic Test: Cytobrush
During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.




Primary Outcome Measures :
  1. detection of specific IgE Antibodies in colon [ Time Frame: 1 hour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients with suspicion of food intolerance and confirmed food allergy

Exclusion Criteria:

  • pregnant and patients under allergy medication (antihistaminic, cortison)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151252


Contacts
Contact: Yurdaguel Zopf, Prof yurdaguel.zopf@uk-erlangen.de
Contact: Esther Tietz esther.tietz@uk-erlangen.de

Locations
Germany
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91052
Contact: Yurdaguel Zopf, Prof       yurdaguel.zopf@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03151252     History of Changes
Other Study ID Numbers: Foodallergy in Colon
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases