Pilotstudie Zur Untersuchung Der Wirkung Einer Oralen Supplementation Von Diaminooxidase (DAOsin®) Bei Histamin-Intoleranz in Bezug Auf Die Steigerung Der Erniedrigten Endogenen Diaminooxidase-Aktivität
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in baseline activity of diamine oxidase activity in serum
研究概览
简要总结
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake. In this uncontrolled, interventional pilot study the effect of an oral diamine oxidase substitution (DAOsin) on the reduced endogenous diamine oxidase activity in histamine intolerant patients will be examined.
Patients with a low endogenous diamine oxidase activity (below 10 Units/ml) take DAOsin for one month 3 times a day. During this month the diamine oxidase activity is tested biweekly. Afterwards a follow up period of one month without taking DAOsin follows. Again the diamine oxidase activity is tested biweekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diamine oxidase activity < 10 U/ml
- •>= 2 symptoms of histamine intolerance after consumption of histamine containing food
- •18 to 80 years
- •no lactose intolerance
- •no fructose intolerance
- •no tissue transglutaminase antibodies in serum
排除标准
- •pregnancy and nursing
- •cardiopathy
- •instable hypertonie
- •asthma bronchial
- •lactose intolerance, fructose intolerance, coeliac disease
- •severe liver and kidney diseases
- •Known food and other allergies
- •participation in clinical study the last 4 weeks
- •recent (3 months) operation affecting the gastrointestinal tract
- •maligne, infectious or autoimmune gastrointestinal diseases (e.g. IBD)
- •taking histamine liberating drugs on a regular basis
- •taking diamine oxidase inhibiting drugs on a regular basis
- •taking diamine oxidase supplements on a regular basis in the last 4 weeks
- •H1 blocker or Montelukast Therapy 4 month before study start
- •Taking anti histaminica
- •Taking zinc preparations
- •drug, alcohol, pharmaceutical abuses
- •heavy smoking (>15 cigarettes a day)
- •Known HIV infection
- •known acute or chronic hepatitis B and C infection
研究组 & 干预措施
DAOsin treatment
Patients suffering from histamine intolerance and a diamin oxidase activity below 10 Units/ml get a DAOsin treatment for one month 3 times a day.
干预措施: DAOsin (Dietary Supplement)
结局指标
主要结局
Change in baseline activity of diamine oxidase activity in serum
时间窗: 1 month treatment with 1 month follow up
The activity of diamine oxidase is reduced in patients suffering from histamine intolerance. Supplementation with diamine oxidase helps to reduce the level of histamine coming from food entering the circulation. It is already described that people suffering from histamine intolerance following a histamine reduced diet increase their diamine oxidase activity. The purpose is to test if an additional reduction of probably hidden sources of histamine in food through the administration of DAOsin helps to increase the endogenous diamine oxidase activity even further.
次要结局
- Global assessment(1 month with 1 month follow up)
- Symptoms of histamine intolerance(1 month with 1 month follow up)
- Histamine level in plasma(1 month with 1 month follow up)