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Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03198455
Enrollment
60
Registered
2017-06-26
Start date
2016-02-29
Completion date
2016-10-31
Last updated
2017-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pollen; Allergy, Asthma

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.

Interventions

DIETARY_SUPPLEMENTAgaricus blazei Murill-based mushroom extract, Andosan™

Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™

OTHERPlacebo

Drinking water with food coloring and salt

Sponsors

University of Oslo
CollaboratorOTHER
ImmunoPharma AS
CollaboratorINDUSTRY
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
QuestionnaireChange from baseline at mid-season at approximately 3 months and after end of season at approx 6 monthsQuestionnaire about allergy and asthma symptoms and medication

Secondary

MeasureTime frameDescription
Total IgE in serumChange from baseline at approximately 3 months and 6 monthsTotal IgE (kU/l) for all allergies
IgE anti-rBet v 1 in serum against birch pollen allergyChange from baseline at approximately 3 months and 6 monthsSpecific IgE (kUA/l) to rBet v 1 allergen
IgE anti-t3 in serum against birch pollen allergyChange from baseline at approximately 3 months and 6 monthsSpecific IgE (kUA/l) to t3 Birch pollen extract
Basophil Activation Test (BAT)Change from baseline at approximately 3 months and 6 monthsBasophil granulocytes are isolated from venous blood samples of study participants
Cytokines in serumChange from baseline at approximately 6 monthsTh1, Th2, pro-and anti-inflammatory cytokines (pg/ml) in plasma was measured by Luminex multi cytokine kit analysis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026