AllergyNCT02293343
24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance
An observational study of Allergy and IBS, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine in plasma, urine and stool were realized. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- blood profile
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to May 2017
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects, patients with high IgE level and patients with afflictions, but no high IgE level
Who may be able to join
- healthy subjects
- appropriate invalid persons
Who cannot join
- pregnant and weaning persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance: Correlations Between Subjective Affliction and Measured Histamine Parameter
Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and IgE Antibodies were measured.
- Being tested
- blood profile
- Keywords
- histamine profile, IgE Antibodies
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood profileOther
| Study group | Role | What they receive |
|---|---|---|
| control group | healthy subjects Receives: Other: blood profile | |
| IgE positive | patients with high IgE level in serum Receives: Other: blood profile | |
| IBS patients | patients with afflictions, but no high IgE level and suspicion on histamine intolerance Receives: Other: blood profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histamine
Measured: 24 hrs
Secondary outcomes (1)
diaminoxidase
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2017
- Study completionMay 2017
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 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
- NCT02293343
- Sponsor's protocol ID
- Histamine profile 1
- Status last verified
- May 2017
- First submitted
- 13 Nov 2014
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pinzer TC, Tietz E, Waldmann E, Schink M, Neurath MF, Zopf Y. Circadian profiling reveals higher histamine plasma levels and lower diamine oxidase serum activities in 24% of patients with suspected histamine intolerance compared to food allergy and controls. Allergy. 2018 Apr;73(4):949-957. doi: 10.1111/all.13361. Epub 2017 Dec 15.
PubMed 29154390
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance: Correlations Between Subjective Affliction and Measured Histamine Parameter
- ClinicalTrials.gov ID
- NCT02293343
- Acronym / sponsor ID
- Histamine profile 1
- Keywords
- histamine profile, IgE Antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Nov 2014 (estimated)
- 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.
Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and IgE Antibodies were measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: blood profilehealthy subjects |
| IgE positive | – | Other: blood profilepatients with high IgE level in serum |
| IBS patients | – | Other: blood profilepatients with afflictions, but no high IgE level and suspicion on histamine intolerance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects, patients with high IgE level and patients with afflictions, but no high IgE level
Key inclusion criteria (2 listed)
- healthy subjects
- appropriate invalid persons
Key exclusion criteria (1 listed)
- pregnant and weaning persons
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 |
|---|---|---|
| blood profile | Other | IBS patients, IgE positive, control group |
Primary outcome
Histamine
Time frame: 24 hrs
1 secondary outcome
diaminoxidase
Time frame: 24 hrs
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 11 May 2017.
- Derived from this study: PubMed 29154390Pinzer TC, Tietz E, Waldmann E, Schink M, Neurath MF, Zopf Y. Circadian profiling reveals higher histamine plasma levels and lower diamine oxidase serum activities in 24% of patients with suspected histamine intolerance compared to food allergy and controls. Allergy. 2018 Apr;73(4):949-957. doi: 10.1111/all.13361. Epub 2017 Dec 15.
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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?
An observational study of Allergy and IBS, 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 2 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 11 May 2017. 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?
Histamine (time frame: 24 hrs). 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 NCT02293343, 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 11 May 2017.