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.

Study Overview

• Status: Completed
• Conditions: Pollen; Allergy, Asthma
• Intervention / Treatment: Dietary supplement: Agaricus blazei Murill-based mushroom extract, Andosan™; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Questionnaire about allergy and asthma symptoms and medication	Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total IgE in serum	Total IgE (kU/l) for all allergies	Change from baseline at approximately 3 months and 6 months
IgE anti-rBet v 1 in serum against birch pollen allergy	Specific IgE (kUA/l) to rBet v 1 allergen	Change from baseline at approximately 3 months and 6 months
IgE anti-t3 in serum against birch pollen allergy	Specific IgE (kUA/l) to t3 Birch pollen extract	Change from baseline at approximately 3 months and 6 months
Basophil Activation Test (BAT)	Basophil granulocytes are isolated from venous blood samples of study participants	Change from baseline at approximately 3 months and 6 months
Cytokines in serum	Th1, Th2, pro-and anti-inflammatory cytokines (pg/ml) in plasma was measured by Luminex multi cytokine kit analysis	Change from baseline at approximately 6 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; ImmunoPharma AS

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (ACTUAL): June 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2015/716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No