Pollen; Allergy, AsthmaNCT03198455
Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?
A study testing Agaricus blazei Murill-based mushroom extract, Andosan™ in people with Pollen; Allergy, Asthma, run by Oslo University Hospital.
Trial summary
Asthma and allergy is 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pollen; Allergy, Asthma
- What is being tested?
- Agaricus blazei Murill-based mushroom extract, Andosan™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Blood donors with birch pollen-derived allergy and asthma
Who cannot join
- Blood donors with other types of allergy and blood donors with Birch pollen allergy who are would not be in Southern Norway during most of the pollen season
About this study
Asthma and allergy is 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. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway. Blood donors and possibly patients with pollen-derived allergy and asthma will be included in the study.The aim is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in man as it has in mice, and ii) reduces drug use and increases frequency of blood donations. Blood donors or patients who are recruited with informed consent will be given Andosan™ or placebo orally as add-on treatment to ordinary treatment for 7 weeks during the Birch pollen season, and specific IgE will be measured before, during and after the intervention, in addition to basophil activation testing and filling out of a questionnaire.
Read the detailed description
Blood donors at Oslo University Hospital (OUH) Blood Bank with self-reported birch pollen allergy and/or asthma were recruited for the study during last 4 months of 2015 and first 2 months of 2016. They signed an informed consent form for the study and were randomized into Andosan™ and placebo Groups. The PI (MD) had the study key and the participants in the study were handled by other staff (nurses and bioengineers) at the blood bank. The participants were given a questionnaire that was filled out before and after the study. Before, during and after the study also blood samples were taken for allergy testing (IgE, BAT) or cytokine profiles. When the participants visited the blood bank after 3.5 weeks, they brought the study medicine vessel (plastic container) that was controlled for remaining study medicine (all should have been used) and given new study medicine for the remaining study period (3.5 weeks). The participants were also asked about possible side effects of the study medicine. In the intervention arm, Agaricus blazei-based mushroom extract Andosan™, was given, which is produced as Health food in Japan and imported as food to Norway and provided for the study by Immunopharma company, Norway. Data were collected and analyzed together after the study. Statistical help was solicited from an OUH statistician.
- Conditions
- Pollen; Allergy, Asthma
- Being tested
- Agaricus blazei Murill-based mushroom extract, Andosan™, Placebo
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agaricus blazei Murill-based mushroom extract, Andosan™Dietary supplement
Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™
PlaceboOther
Drinking water with food coloring and salt
| Study group | Role | What they receive |
|---|---|---|
| Andosan | Experimental | The Agaricus blazei Murill-based mushroom extract, Andosan™, is given as one dosage 60 ml/day orally for 2 months. The intervention solution is given for 1 month's consumption at a time in a neutral plastic container Receives: Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™ |
| Placebo | Placebo comparator | The placebo is drinking water with brownish food coloring, given as one dosage 60 ml/day orally for 2 months. The placebo solution is given for 1 month's consumption at a time in a neutral plastic container (same as for intervention/experimental solution). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Questionnaire about allergy and asthma symptoms and medication
Measured: Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months
Secondary outcomes (5)
Total IgE in serum
Total IgE (kU/l) for all allergies
Measured: Change from baseline at approximately 3 months and 6 months
IgE anti-rBet v 1 in serum against birch pollen allergy
Specific IgE (kUA/l) to rBet v 1 allergen
Measured: Change from baseline at approximately 3 months and 6 months
IgE anti-t3 in serum against birch pollen allergy
Specific IgE (kUA/l) to t3 Birch pollen extract
Measured: Change from baseline at approximately 3 months and 6 months
Basophil Activation Test (BAT)
Basophil granulocytes are isolated from venous blood samples of study participants
Measured: Change from baseline at approximately 3 months and 6 months
Cytokines in serum
Th1, Th2, pro-and anti-inflammatory cytokines (pg/ml) in plasma was measured by Luminex multi cytokine kit analysis
Measured: Change from baseline at approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study startFeb 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pollen; Allergy, AsthmaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, ImmunoPharma AS
- Responsible party
- Principal investigator, Lise Sofie Haug Nissen-Meyer, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198455
- Sponsor's protocol ID
- 2015/716
- Status last verified
- Jun 2017
- First submitted
- 15 Mar 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?
- ClinicalTrials.gov ID
- NCT03198455
- Acronym / sponsor ID
- 2015/716
- Conditions
- Pollen; Allergy, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, ImmunoPharma AS
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma and allergy is 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. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway. Blood donors and possibly patients with pollen-derived allergy and asthma will be included in the study.The aim is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in man as it has in mice, and ii) reduces drug use and increases frequency of blood donations. Blood donors or patients who are recruited with informed consent will be given Andosan™ or placebo orally as add-on treatment to ordinary treatment for 7 weeks during the Birch pollen season, and specific IgE will be measured before, during and after the intervention, in addition to basophil activation testing and filling out of a questionnaire.
Detailed description
Blood donors at Oslo University Hospital (OUH) Blood Bank with self-reported birch pollen allergy and/or asthma were recruited for the study during last 4 months of 2015 and first 2 months of 2016. They signed an informed consent form for the study and were randomized into Andosan™ and placebo Groups. The PI (MD) had the study key and the participants in the study were handled by other staff (nurses and bioengineers) at the blood bank. The participants were given a questionnaire that was filled out before and after the study. Before, during and after the study also blood samples were taken for allergy testing (IgE, BAT) or cytokine profiles. When the participants visited the blood bank after 3.5 weeks, they brought the study medicine vessel (plastic container) that was controlled for remaining study medicine (all should have been used) and given new study medicine for the remaining study period (3.5 weeks). The participants were also asked about possible side effects of the study medicine. In the intervention arm, Agaricus blazei-based mushroom extract Andosan™, was given, which is produced as Health food in Japan and imported as food to Norway and provided for the study by Immunopharma company, Norway. Data were collected and analyzed together after the study. Statistical help was solicited from an OUH statistician.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Andosan | Experimental | Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™The Agaricus blazei Murill-based mushroom extract, Andosan™, is given as one dosage 60 ml/day orally for 2 months. The intervention solution is given for 1 month's consumption at a time in a neutral plastic container |
| Placebo | Placebo comparator | Other: PlaceboThe placebo is drinking water with brownish food coloring, given as one dosage 60 ml/day orally for 2 months. The placebo solution is given for 1 month's consumption at a time in a neutral plastic container (same as for intervention/experimental solution). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Blood donors with birch pollen-derived allergy and asthma
Key exclusion criteria (1 listed)
- Blood donors with other types of allergy and blood donors with Birch pollen allergy who are would not be in Southern Norway during most of the pollen season
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agaricus blazei Murill-based mushroom extract, Andosan™Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™ | Dietary supplement | Andosan |
| PlaceboDrinking water with food coloring and salt | Other | Placebo |
Primary outcome
Questionnaire
Time frame: Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months
Questionnaire about allergy and asthma symptoms and medication
5 secondary outcomes
Total IgE in serum
Time frame: Change from baseline at approximately 3 months and 6 months
IgE anti-rBet v 1 in serum against birch pollen allergy
Time frame: Change from baseline at approximately 3 months and 6 months
IgE anti-t3 in serum against birch pollen allergy
Time frame: Change from baseline at approximately 3 months and 6 months
Basophil Activation Test (BAT)
Time frame: Change from baseline at approximately 3 months and 6 months
Cytokines in serum
Time frame: Change from baseline at approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Agaricus blazei Murill-based mushroom extract, Andosan™ in people with Pollen; Allergy, Asthma, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: Change from baseline at mid-season at approximately 3 months and after end of season at approx 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.