24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance

NCT ID: NCT02293343

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergy IBS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

healthy subjects

blood profile

Intervention Type OTHER

IgE positive

patients with high IgE level in serum

blood profile

Intervention Type OTHER

IBS patients

patients with afflictions, but no high IgE level and suspicion on histamine intolerance

blood profile

Intervention Type OTHER

Interventions

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blood profile

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy subjects
* appropriate invalid persons

Exclusion Criteria

* pregnant and weaning persons
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-NĂĽrnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29154390 (View on PubMed)

Other Identifiers

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Histamine profile 1

Identifier Type: -

Identifier Source: org_study_id

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