Andosan in Allergic and Asthma Patients

University Hospital, Akershus

Status: Completed

Conditions: Immune Tolerance; Allergic Rhinoconjunctivitis; Allergic Asthma

Treatments: Dietary Supplement: Andosan; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05192720

20/01869

Details and patient eligibility

About

Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy experience clinical and biochemical improvement in their disease.

A prospective randomised study comparing the mushroom extract with placebo.

Full description

Asthma and allergy are 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. Positive effects on allergy were also shown in a RCT on blood donors with selfreported allergy. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway.

The aim of this study is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in patients as it has in mice, and as earlier shown in a study on blood donors with allergy ii) wether patients taking Andosan has any clinical impact on asthma while taken as supplementary treatment in addition to other medication compared to a placebo group while going through allergen specific immunotherapy (ASIT).

If the extract shows effect on these patients it support the hypotheses that Andosan helps against atopic diseases and facilitate the shift from Th-2 to Th-1 responses at a cellular level.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy).
• Age above 18.
• Able to understand written and oral Norwegian

Exclusion criteria

• none other than not meeting the inclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

Andosan

Experimental group

Description:

The Agaricus blazei Murill-based mushroom extract, Andosan™, is given as one dosage 100 ml/day orally for 1 month. The intervention solution is given in a neutral plastic container

Treatment:

Dietary Supplement: Andosan

Placebo

Placebo Comparator group

Description:

The placebo is drinking water with brownish food coloring, given as one dosage 100 ml/day orally for 1 month. The placebo solution is given in a neutral plastic container (same as for intervention/experimental solution).

Treatment:

Dietary Supplement: Placebo