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OpenTrials
Completed

NCT Number: NCT03198455

Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

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.

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Key information

Conditions

Pollen; Allergy, Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Agaricus blazei Murill-based mushroom extract, Andosan™

Dietary Supplement

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

Placebo

Other

Drinking water with food coloring and salt

Primary outcomes

  1. Questionnaire

    Time frame: Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months

    Questionnaire about allergy and asthma symptoms and medication

Secondary outcomes

  1. Total IgE in serum

    Time frame: Change from baseline at approximately 3 months and 6 months

    Total IgE (kU/l) for all allergies

  2. IgE anti-rBet v 1 in serum against birch pollen allergy

    Time frame: Change from baseline at approximately 3 months and 6 months

    Specific IgE (kUA/l) to rBet v 1 allergen

  3. IgE anti-t3 in serum against birch pollen allergy

    Time frame: Change from baseline at approximately 3 months and 6 months

    Specific IgE (kUA/l) to t3 Birch pollen extract

  4. Basophil Activation Test (BAT)

    Time frame: Change from baseline at approximately 3 months and 6 months

    Basophil granulocytes are isolated from venous blood samples of study participants

  5. Cytokines in serum

    Time frame: Change from baseline at approximately 6 months

    Th1, Th2, pro-and anti-inflammatory cytokines (pg/ml) in plasma was measured by Luminex multi cytokine kit analysis

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • ImmunoPharma AS
  • University of Oslo

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2017
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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