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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Reduction of biogenic amine symptoms (determined via symptom score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons suspected of suffering from BAIS (BAIS Score ≥ 50) according the the questionaire used for histamine intolerance so far
排除标准
- •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
结局指标
主要结局
Reduction of biogenic amine symptoms (determined via symptom score)
时间窗: 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.
次要结局
- Serological parameters(Up to 90 min after provocation)