Improvement of Foodallergy Diagnostic in Gastrointestinal Tract

Improvement of Foodallergy Diagnostic in Gastrointestinal Tract With a New Kind of Sampling

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.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Diagnostic test: Cytobrush

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
detection of specific IgE Antibodies in colon	1 hour

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Publications and helpful links

General Publications

• Dieterich W, Tietz E, Kohl M, Konturek PC, Rath T, Neurath MF, Zopf Y. Food Intolerance of Unknown Origin: Caused by Mucosal Inflammation? A Pilot Study. Clin Transl Gastroenterol. 2021 Feb 17;12(2):e00312. doi: 10.14309/ctg.0000000000000312.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: Foodallergy in Colon

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No