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| Name | Class |
|---|---|
| Medical University of Graz | OTHER |
| Sciotec Diagnostic Technologies GmbH | INDUSTRY |
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This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.
The clinical picture of the so-called histamine intolerance has been described by various authors since the 1990ies. However, the existence of this multifactorial condition is also being contested due to the lack of both a positive definition and unambiguous diagnostics. Various provocation studies using pure histamine or histamine-containing foods support the existence of the disease pattern, however many questions still remain open.
A lack of diamine oxidase (DAO) is considered the etiological cause of the condition. DAO is an enzyme known to degrade a wide array of biogenic amines. The aim of this study is to provoke a response in patients by oral administration of a defined mixture of biogenic amines. By administration of DAO before provocation an attenuation of the symptoms is to be expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAOSiN®/ Placebo & ProvokAmin® Ingestion | Experimental | A sample of blood is drawn from Patient, blood pressure & pulse are recorded. Patient will ingest 2 capsules of either DAOSiN® or Placebo, followed by 2 tablets of ProvokAmin 20 minutes later. After an additional 40 minutes blood pressure and pulse are recorded and another sample of blood is drawn. Patient is handed a questionaire for self-evaluation to record any symptoms for the following After between 7 and 15 days the whole cycle is repeated switching between active treatment and Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAOSiN®/ Placebo & ProvokAmin® Ingestion | Dietary Supplement | Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin® |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of biogenic amine symptoms (determined via symptom score) | The primary parameter is the reduction of clinical symptoms caused by the ingestion of biogenic amines by the preventive oral administration of DAOSiN®. A symptom score quantifying the subjective single symptoms is used as measuring parameter. | 24 hrs after start of provocation |
| Measure | Description | Time Frame |
|---|---|---|
| Serological parameters | These parameters are ascertained: DAO activity and concentration of histamine in serum; blood pressure & pulse measurement before and 30/60/90 min post provocation | Up to 90 min after provocation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Missbichler, PhD | Sciotec Diagnostic Technologies GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Dermatology and Venereology, Medical University of Graz | Graz | 8036 | Austria |
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| ID | Term |
|---|---|
| D011674 | Pulse |
| ID | Term |
|---|---|
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Drawing blood, measuring BP & pulse | Procedure | Taking of a blood sample and recording of blood pressure & pulse |
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