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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
72
Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin®
Taking of a blood sample and recording of blood pressure \& pulse
Department of Environmental Dermatology and Venereology, Medical University of Graz
Graz, Austria
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.
Time frame: 24 hrs after start of provocation
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
Time frame: Up to 90 min after provocation
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