Clinical trial NCT03198455: Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?
Official title: Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pollen; Allergy, Asthma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: ImmunoPharma AS
First posted: 2017-06-26
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire
timeFrame: Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months
Secondary outcomes:
measure: Total IgE in serum
timeFrame: Change from baseline at approximately 3 months and 6 months
measure: IgE anti-rBet v 1 in serum against birch pollen allergy
timeFrame: Change from baseline at approximately 3 months and 6 months
measure: IgE anti-t3 in serum against birch pollen allergy
timeFrame: Change from baseline at approximately 3 months and 6 months
measure: Basophil Activation Test (BAT)
timeFrame: Change from baseline at approximately 3 months and 6 months
measure: Cytokines in serum
timeFrame: Change from baseline at approximately 6 months
Other outcomes:
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