Skip to main content
OpenTrials
Completed

NCT Number: NCT05192720

Andosan in Allergic and Asthma Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus university hospital

Lørenskog, Akershus, 1478, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AndoSan

Dietary Supplement

See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.

Placebo

Dietary Supplement

drinking water with food colour

Primary outcomes

  1. FEV1

    Time frame: 20 days

    Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention.

Secondary outcomes

  1. Oscillometry

    Time frame: 20 days to four weeks

    change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry.

  2. Questionnaire ACT

    Time frame: four weeks

    Change in asthma symptoms, as measured by the asthma control test

  3. Questionnaire RQLQ

    Time frame: four weeks

    Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality)

  4. Passive basophil cell activation in serum

    Time frame: four weeks

    Difference in activation of basophil cells measured in serum before and after intervention

  5. Immunoglobulin E in serum

    Time frame: four weeks

    difference in concentration before and after intervention

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • ImmunoPharma AS
  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 14, 2022
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.