A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation
- Conditions
- Histamine Intolerance
- Interventions
- Dietary Supplement: DAOSiN®/ Placebo & ProvokAmin® IngestionProcedure: Drawing blood, measuring BP & pulse
- Registration Number
- NCT02418221
- Lead Sponsor
- IPSC AG
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Persons suspected of suffering from BAIS (BAIS Score ≥ 50) according the the questionaire used for histamine intolerance so far
- pregnancy
- coronary heart disease
- labile hypertension
- bronchial asthma
- periodical therapy using H1-blockers
- chirurgical intervention with the GI tract within the previous 3 months
- participation in a clinical trial within the previous 4 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DAOSiN®/ Placebo & ProvokAmin® Ingestion Drawing blood, measuring BP & pulse 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. DAOSiN®/ Placebo & ProvokAmin® Ingestion DAOSiN®/ Placebo & ProvokAmin® Ingestion 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.
- Primary Outcome Measures
Name Time Method Reduction of biogenic amine symptoms (determined via symptom score) 24 hrs after start of provocation 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.
- Secondary Outcome Measures
Name Time Method Serological parameters Up to 90 min after provocation These parameters are ascertained: DAO activity and concentration of histamine in serum; blood pressure \& pulse measurement before and 30/60/90 min post provocation
Trial Locations
- Locations (1)
Department of Environmental Dermatology and Venereology, Medical University of Graz
🇦🇹Graz, Austria