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Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

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ClinicalTrials.gov Identifier: NCT03198455
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
University of Oslo
ImmunoPharma AS
Information provided by (Responsible Party):
Lise Sofie Haug Nissen-Meyer, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Pollen; Allergy, Asthma Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™ Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?
Actual Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma

Arm Intervention/treatment
Experimental: Andosan
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™
Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™

Placebo Comparator: Placebo
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
Drinking water with food coloring and salt




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Lise Sofie Haug Nissen-Meyer, Project leader, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03198455     History of Changes
Other Study ID Numbers: 2015/716
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases