Andosan in Allergic and Asthma Patients

Not Applicable

Completed

• Conditions: Allergic Asthma; Immune Tolerance; Allergic Rhinoconjunctivitis
• Interventions: Dietary Supplement: Andosan; Dietary Supplement: Placebo

• Registration Number: NCT05192720
• Lead Sponsor: University Hospital, Akershus

Brief 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.

Study Timeline

• Study Start: 2021-08-31
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Andosan	Andosan	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
Placebo	Placebo	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).

Primary Outcome Measures

Name	Time	Method
FEV1	20 days	Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention.

Secondary Outcome Measures

Name	Time	Method
Immunoglobulin E in serum	four weeks	difference in concentration before and after intervention
Questionnaire ACT	four weeks	Change in asthma symptoms, as measured by the asthma control test
Oscillometry	20 days to four weeks	change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry.
Questionnaire RQLQ	four weeks	Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality)
Passive basophil cell activation in serum	four weeks	Difference in activation of basophil cells measured in serum before and after intervention

Trial Locations

Locations (1)

Akershus university hospital; 🇳🇴 Lørenskog, Viken, Norway