Effect of Supplementary Treatment With Agaricus Blazei Based Mushroom Extract, Andosan, on Patients With Asthma and Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- FEV1
研究概览
简要总结
Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy experience clinical and biochemical improvement in their disease.
A prospective randomised study comparing the mushroom extract with placebo.
详细描述
Asthma and allergy are increasing in Norway and Western countries. Treatment is still mostly symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as Andosan™, have been shown to protect against asthma and allergy in murine models by changing the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune system. Positive effects on allergy were also shown in a RCT on blood donors with selfreported allergy. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway.
The aim of this study is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in patients as it has in mice, and as earlier shown in a study on blood donors with allergy ii) wether patients taking Andosan has any clinical impact on asthma while taken as supplementary treatment in addition to other medication compared to a placebo group while going through allergen specific immunotherapy (ASIT).
If the extract shows effect on these patients it support the hypotheses that Andosan helps against atopic diseases and facilitate the shift from Th-2 to Th-1 responses at a cellular level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
the patients do not know if they get Andosan or placebo.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy).
- •Age above
- •Able to understand written and oral Norwegian
排除标准
- •- none other than not meeting the inclusion criteria
结局指标
主要结局
FEV1
时间窗: 20 days
Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention.
次要结局
- Questionnaire ACT(four weeks)
- Oscillometry(20 days to four weeks)
- Questionnaire RQLQ(four weeks)
- Immunoglobulin E in serum(four weeks)
- Passive basophil cell activation in serum(four weeks)
研究者
Faiza Mahmood
Senior Consultant, Department of Immunology and Transfusion Medicine
University Hospital, Akershus
