Histamine Intolerance Clinical Trial
Official title:
A Doubleblind, Placebo-controlled, Cross-over Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase (DAOSiN®) Supplementation in Case of DAO Enzyme Deficiency
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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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05676346 -
Genetic DAO Deficiency and Lower Urinary Tract Symptoms
|
||
| Completed |
NCT03298568 -
Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity
|
N/A |