跳至主要内容
临床试验/NCT05192720
NCT05192720已完成不适用

Effect of Supplementary Treatment With Agaricus Blazei Based Mushroom Extract, Andosan, on Patients With Asthma and Allergy

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年8月31日最近更新:
适应症

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

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

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faiza Mahmood

Senior Consultant, Department of Immunology and Transfusion Medicine

University Hospital, Akershus

研究点 (2)

Loading locations...

相似试验