Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

Study Overview
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Brief Summary
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Asthma and allergy is 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. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway. Blood donors and possibly patients with pollen-derived allergy and asthma will be included in the study.The aim is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in man as it has in mice, and ii) reduces drug use and increases frequency of blood donations. Blood donors or patients who are recruited with informed consent will be given Andosan™ or placebo orally as add-on treatment to ordinary treatment for 7 weeks during the Birch pollen season, and specific IgE will be measured before, during and after the intervention, in addition to basophil activation testing and filling out of a questionnaire.

Detailed Description
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Blood donors at Oslo University Hospital (OUH) Blood Bank with self-reported birch pollen allergy and/or asthma were recruited for the study during last 4 months of 2015 and first 2 months of 2016. They signed an informed consent form for the study and were randomized into Andosan™ and placebo Groups. The PI (MD) had the study key and the participants in the study were handled by other staff (nurses and bioengineers) at the blood bank. The participants were given a questionnaire that was filled out before and after the study. Before, during and after the study also blood samples were taken for allergy testing (IgE, BAT) or cytokine profiles. When the participants visited the blood bank after 3.5 weeks, they brought the study medicine vessel (plastic container) that was controlled for remaining study medicine (all should have been used) and given new study medicine for the remaining study period (3.5 weeks). The participants were also asked about possible side effects of the study medicine. In the intervention arm, Agaricus blazei-based mushroom extract Andosan™, was given, which is produced as Health food in Japan and imported as food to Norway and provided for the study by Immunopharma company, Norway. Data were collected and analyzed together after the study. Statistical help was solicited from an OUH statistician.

Official Title
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Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

Conditions
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Pollen; Allergy, Asthma

Intervention / Treatment
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* Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood donors with birch pollen-derived allergy and asthma Exclusion Criteria: Blood donors with other types of allergy and blood donors with Birch pollen allergy who are would not be in Southern Norway during most of the pollen season
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Andosan<br>The Agaricus blazei Murill-based mushroom extract, Andosan™, is given as one dosage 60 ml/day orally for 2 months. The intervention solution is given for 1 month's consumption at a time in a neutral plastic container | Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™<br>* Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™<br>|
| Placebo Comparator: Placebo<br>The placebo is drinking water with brownish food coloring, given as one dosage 60 ml/day orally for 2 months. The placebo solution is given for 1 month's consumption at a time in a neutral plastic container (same as for intervention/experimental solution). | Other: Placebo<br>* Drinking water with food coloring and salt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | Questionnaire about allergy and asthma symptoms and medication | Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total IgE in serum | Total IgE (kU/l) for all allergies | Change from baseline at approximately 3 months and 6 months | 
| IgE anti-rBet v 1 in serum against birch pollen allergy | Specific IgE (kUA/l) to rBet v 1 allergen | Change from baseline at approximately 3 months and 6 months | 
| IgE anti-t3 in serum against birch pollen allergy | Specific IgE (kUA/l) to t3 Birch pollen extract | Change from baseline at approximately 3 months and 6 months | 
| Basophil Activation Test (BAT) | Basophil granulocytes are isolated from venous blood samples of study participants | Change from baseline at approximately 3 months and 6 months | 
| Cytokines in serum | Th1, Th2, pro-and anti-inflammatory cytokines (pg/ml) in plasma was measured by Luminex multi cytokine kit analysis | Change from baseline at approximately 6 months |