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Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

Primary Purpose

Pollen; Allergy, Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Agaricus blazei Murill-based mushroom extract, Andosan™
Placebo
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pollen; Allergy, Asthma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Andosan

    Placebo

    Arm Description

    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

    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).

    Outcomes

    Primary Outcome Measures

    Questionnaire
    Questionnaire about allergy and asthma symptoms and medication

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 15, 2017
    Last Updated
    June 22, 2017
    Sponsor
    Oslo University Hospital
    Collaborators
    University of Oslo, ImmunoPharma AS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03198455
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (Actual)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    University of Oslo, ImmunoPharma AS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pollen; Allergy, Asthma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Andosan
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Agaricus blazei Murill-based mushroom extract, Andosan™
    Intervention Description
    Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Drinking water with food coloring and salt
    Primary Outcome Measure Information:
    Title
    Questionnaire
    Description
    Questionnaire about allergy and asthma symptoms and medication
    Time Frame
    Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months
    Secondary Outcome Measure Information:
    Title
    Total IgE in serum
    Description
    Total IgE (kU/l) for all allergies
    Time Frame
    Change from baseline at approximately 3 months and 6 months
    Title
    IgE anti-rBet v 1 in serum against birch pollen allergy
    Description
    Specific IgE (kUA/l) to rBet v 1 allergen
    Time Frame
    Change from baseline at approximately 3 months and 6 months
    Title
    IgE anti-t3 in serum against birch pollen allergy
    Description
    Specific IgE (kUA/l) to t3 Birch pollen extract
    Time Frame
    Change from baseline at approximately 3 months and 6 months
    Title
    Basophil Activation Test (BAT)
    Description
    Basophil granulocytes are isolated from venous blood samples of study participants
    Time Frame
    Change from baseline at approximately 3 months and 6 months
    Title
    Cytokines in serum
    Description
    Th1, Th2, pro-and anti-inflammatory cytokines (pg/ml) in plasma was measured by Luminex multi cytokine kit analysis
    Time Frame
    Change from baseline at approximately 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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