NCT03151252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

8.2 years

First QC Date

May 10, 2017

Last Update Submit

July 3, 2024

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

  • detection of specific IgE Antibodies in colon

    1 hour

Study Arms (3)

Food allergy

OTHER

Patients with confirmed foodspecific- IgE antibodies in blood

Diagnostic Test: Cytobrush

healthy controls

OTHER

participants without foodspecific- IgE antibodies in blood and other gastrointestinal symptoms

Diagnostic Test: Cytobrush

gastointestinal symptoms without foodallergy in blood

OTHER

Patients without foodspecific- IgE antibodies in blood, but with gastrointestinal symptoms

Diagnostic Test: Cytobrush

Interventions

CytobrushDIAGNOSTIC_TEST

During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.

Food allergygastointestinal symptoms without foodallergy in bloodhealthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, 91052, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33600102DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 12, 2017

Study Start

October 1, 2014

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

DE(1)