Akershus university hospital
Lørenskog, Akershus, 1478, Norway
NCT Number: NCT05192720
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lørenskog, Akershus, 1478, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.
drinking water with food colour
Time frame: 20 days
Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention.
Time frame: 20 days to four weeks
change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry.
Time frame: four weeks
Change in asthma symptoms, as measured by the asthma control test
Time frame: four weeks
Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality)
Time frame: four weeks
Difference in activation of basophil cells measured in serum before and after intervention
Time frame: four weeks
difference in concentration before and after intervention
University Hospital, Akershus
Other
Effect of Supplementary Treatment With Agaricus Blazei Based Mushroom Extract, Andosan, on Patients With Asthma and Allergy
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