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Clinical Trial Summary

Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy or who have asthma proven by metacholine provocation test, experience clinical and biochemical improvement in their disease. A prospective randomised study comparing the mushroom extract with placebo.

Clinical Trial Description

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). iii) Investigate if Andosan taken for two weeks has any effect on bronchial reactivity measured through spirometry done five days (as home spirometry twice daily) before and after treatment with Andosan in patients proven to have asthma with bronchial provocation test. 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05192720
Study type Interventional
Source University Hospital, Akershus
Contact Faiza Mahmood
Phone 004767961210
Email [email protected]
Status Recruiting
Phase N/A
Start date August 31, 2021
Completion date December 31, 2022

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