Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

NCT03198455 | Completed DMC

• 1 other identifier: 2015/716
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pollen; Allergy, Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total IgE in serum

  Change from baseline at approximately 3 months and 6 months

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

  Change from baseline at approximately 3 months and 6 months

• IgE anti-t3 in serum against birch pollen allergy

  Change from baseline at approximately 3 months and 6 months

• Basophil Activation Test (BAT)

  Change from baseline at approximately 3 months and 6 months

• Cytokines in serum

  Change from baseline at approximately 6 months

Study Arms (2)

Andosan

EXPERIMENTAL

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™

Placebo

PLACEBO COMPARATOR

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

Interventions

Agaricus blazei Murill-based mushroom extract, Andosan™ DIETARY_SUPPLEMENT

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

Andosan

Placebo OTHER

Drinking water with food coloring and salt

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Blood donors with birch pollen-derived allergy and asthma

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• ImmunoPharma AS: collaborator

MeSH Terms

Conditions

Hypersensitivity; Asthma

Interventions

AndoSan

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: June 26, 2017
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 26, 2017

Record last verified: 2017-06