Clinical Trials Directory

Trials / Completed

CompletedNCT05192720

Andosan in Allergic and Asthma Patients

Effect of Supplementary Treatment With Agaricus Blazei Based Mushroom Extract, Andosan, on Patients With Asthma and Allergy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
University Hospital, Akershus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTAndosanSee also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.
DIETARY_SUPPLEMENTPlacebodrinking water with food colour

Timeline

Start date
2021-08-31
Primary completion
2022-12-31
Completion
2023-02-28
First posted
2022-01-14
Last updated
2024-06-18

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT05192720. Inclusion in this directory is not an endorsement.