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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
34
Akershus university hospital
Lørenskog, Akershus, Norway
FEV1
Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention.
Time frame: 20 days
Oscillometry
change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry.
Time frame: 20 days to four weeks
Questionnaire ACT
Change in asthma symptoms, as measured by the asthma control test
Time frame: four weeks
Questionnaire RQLQ
Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality)
Time frame: four weeks
Passive basophil cell activation in serum
Difference in activation of basophil cells measured in serum before and after intervention
Time frame: four weeks
Immunoglobulin E in serum
difference in concentration before and after intervention
Time frame: four weeks
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