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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| ImmunoPharma AS | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Andosan | Experimental | 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 Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Andosan | Dietary Supplement | See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention. | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oscillometry | change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry. | 20 days to four weeks |
| Questionnaire ACT | Change in asthma symptoms, as measured by the asthma control test |
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Inclusion Criteria:
Exclusion Criteria:
- none other than not meeting the inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Faiza Mahmood | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus university hospital | Lørenskog | Akershus | 1478 | Norway |
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| ID | Term |
|---|---|
| C579023 | AndoSan |
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25-30 patients in each arm receiving Andosan or placebo.
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the patients do not know if they get Andosan or placebo.
| Placebo | Dietary Supplement | drinking water with food colour |
|
| four weeks |
| Questionnaire RQLQ | Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality) | four weeks |
| Passive basophil cell activation in serum | Difference in activation of basophil cells measured in serum before and after intervention | four weeks |
| Immunoglobulin E in serum | difference in concentration before and after intervention | four weeks |