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
About this trial
This is an interventional prevention trial for Pollen; Allergy, Asthma
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
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
NCT ID
NCT03198455
First Posted
March 15, 2017
Last Updated
June 22, 2017
Sponsor
Oslo University Hospital
Collaborators
University of Oslo, ImmunoPharma AS
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
Learn more about this trial
Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?
We'll reach out to this number within 24 hrs