Food AllergyNCT03151252
Improvement of Foodallergy Diagnostic in Gastrointestinal Tract
A study testing Cytobrush in people with Food Allergy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Cytobrush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients with suspicion of food intolerance and confirmed food allergy
Who cannot join
- pregnant and patients under allergy medication (antihistaminic, cortison)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052
About this study
Official title: 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.
- Conditions
- Food Allergy
- Being tested
- Cytobrush
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytobrushDiagnostic test
During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.
| Study group | Role | What they receive |
|---|---|---|
| Food allergy | Other | Patients with confirmed foodspecific- IgE antibodies in blood Receives: Diagnostic Test: Cytobrush |
| healthy controls | Other | participants without foodspecific- IgE antibodies in blood and other gastrointestinal symptoms Receives: Diagnostic Test: Cytobrush |
| gastointestinal symptoms without foodallergy in blood | Other | Patients without foodspecific- IgE antibodies in blood, but with gastrointestinal symptoms Receives: Diagnostic Test: Cytobrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of specific IgE Antibodies in colon
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startOct 2014
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151252
- Sponsor's protocol ID
- Foodallergy in Colon
- Status last verified
- Jul 2024
- First submitted
- 10 May 2017
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33600102
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Foodallergy Diagnostic in Gastrointestinal Tract With a New Kind of Sampling
- ClinicalTrials.gov ID
- NCT03151252
- Acronym / sponsor ID
- Foodallergy in Colon
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food allergy | Other | Diagnostic Test: CytobrushPatients with confirmed foodspecific- IgE antibodies in blood |
| healthy controls | Other | Diagnostic Test: Cytobrushparticipants without foodspecific- IgE antibodies in blood and other gastrointestinal symptoms |
| gastointestinal symptoms without foodallergy in blood | Other | Diagnostic Test: CytobrushPatients without foodspecific- IgE antibodies in blood, but with gastrointestinal symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with suspicion of food intolerance and confirmed food allergy
Key exclusion criteria (1 listed)
- pregnant and patients under allergy medication (antihistaminic, cortison)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytobrushDuring the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush. | Diagnostic test | Food allergy, gastointestinal symptoms without foodallergy in blood, healthy controls |
Primary outcome
detection of specific IgE Antibodies in colon
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 33600102Dieterich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytobrush in people with Food Allergy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of specific IgE Antibodies in colon (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.