Rheumatoid ArthritisAndosan-RANCT01815411
Effect of Andosan in Patients With Rheumatoid Arthritis
A study testing Mushroom extract in people with Rheumatoid Arthritis, run by Egil Johnson at 1 site in Norway.
Trial summary
Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to significant pain, joint destruction and functional decline, and has a substantial economic impact both for sufferers and society. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Mushroom extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to Apr 2018
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Able and willing to give written informed consent, and to comply with the requirements of the study protocol.
- Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis.
- Moderate disease activity based on the clinical evaluation including DAS28-ESR (DAS28 3.2-5.1) [11, 12].
- Stable medication by disease modifying drugs (DMARDs) and systemic glucocorticosteroids for 3 months prior to the inclusion.
Who cannot join
- Lack of cooperativity.
- Clinically significant chronic infection, including positive serology for hepatitis B or C, history of positive HIV status.
- Acute significant infection during the last 3 weeks before the inclusion. Surgery during the last 4 weeks before the inclusion, and during the study period.
- Clinically significant malignancy .
- Drug addiction
- Any inflammatory disease of permanence not related to RA.
Show all 11Show fewer
- Use of prednisolone >7,5 mg daily for 1 month prior to the inclusion.
- Use of biologic treatment including antibodies to cytokines and their receptors for 6 weeks prior to the inclusion.
- Use of intramuscular, intra-articular or intravenous injections of corticosteroids during or within 4 weeks prior to inclusion in the trial.
- Vaccination during the trial.
- Pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to significant pain, joint destruction and functional decline, and has a substantial economic impact both for sufferers and society. Although the etiology of RA is unknown, it is generally accepted that it arises from an interplay of genetic predisposition (in particular, HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g. autoantibody production), and environmental factors. The prevalence and incidence of RA in Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are 2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6). RA is also associated with significant comorbidity; the most important is premature cardiovascular disease that significantly contributes to increased mortality. Compared with the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden, and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids, traditional disease modifying antirheumatic drugs (including methotrexate) and biologic therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy). Also, a considerable portion of the patients are in need of joint replacement surgery and in need of rehabilitation.
However, the treatment opportunities are still not optimal. In a large proportion of the patients, full control of the disease is not possible due to limited effect of available therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new therapeutic alternatives to treat RA.
Since studies on healthy volunteers and IBD-patients support that the mushroom extract AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a pilot study whether this effect also was evident in patients with RA. A potential anti-inflammatory effect could prove beneficial in these seriously ill patients, who accordingly could experience less side effects (edema, granulocytopenia, diminished tissue repair) due to potential reduction number and dose of disease modifying drugs.
Read the detailed description
Main aim: Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) leads to a clinical, biochemical and genetical improvement in RA. The experiment will be carried out for 21 days in 15 eligible RA patients. In order to increase the scientific value of the project we will use, a as far as possible, an age matched control group of RA patients with steady medication and no intervention. The control group of 10-15 patients will be answering the same questionnaires and give the same samples of blood and feces.
Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of Andosan the effect of this therapy on:
- general blood samples (leucocytes, CRP, liver and renal function tests), including erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
- level of blood cytokines and analytes (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/ 17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB, RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in patients
- genetic expression in blood leukocytes (microarray) -number of swollen and tender joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue scale (VAS) for patient's and physician's global assessment of disease activity, life quality (SF-36 version 2), fatigue score.
Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of Andosan the effect of this therapy on:
- general blood samples (leucocytes, CRP, liver and renal function tests), including erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
- level of blood cytokines and analytes (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/ 17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB, RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in patients
- genetic expression in blood leukocytes (microarray) -number of swollen and tender joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue scale (VAS) for patient's and physician's global assessment of disease activity, life quality (SF-36 version 2), fatigue score.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Mushroom extract
- Keywords
- Rheumatoid arthritis, symptom score, fatigue, life quality, cytokines, mRNA expression, Quality of Life, Signs and Symptoms, Indication for Modification of Patient Physical Status
- Medical subject headings
- Arthritis, Rheumatoid, Fatigue, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mushroom extractDietary supplement
The mushroom extract (Andosan) is given orally in doses 30 m x 2 daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Mushroom extract | Experimental | The patients are given the mushroom extract (Andosan) in doses 30 mlx2 per day for 1 days. The experimental group is selected by randomisation. Receives: Dietary Supplement: Mushroom extract |
| Control group | No intervention | The control group is selected by randomisation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score
The symptom score will be registered at day 1 prior to the patients are given Andosan for 21 days, and at day 21 after the patients have consumed Andosan daily for 21 days.
Measured: The duration of the experiment is 3 weeks (21 days)
Secondary outcomes (1)
Cytokine levels in harvested blood from the patients
Cytokine levels will be measured at day 1 prior to ingestion of Andosan and at day 21 after 21 days of Andosan consumption.
Measured: The duration of the experiment is 3 weeks (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMay 2016
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egil Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- ImmunoPharma AS
- Responsible party
- Sponsor-investigator, Egil Johnson, Oslo University Hospital
- Investigators
- Egil Johnson, Md, PhD, Principal investigator, Dep. of gastric- and pediatric surgery, Oslo University Hospital, Ulleval, Kirkeveien 166, 0407 Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815411
- Sponsor's protocol ID
- 2012/1962
- Other IDs
- Egil Johnson
- Acronym
- Andosan-RA
- Status last verified
- Jun 2016
- First submitted
- 14 Mar 2013
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson E, Forland DT, Hetland G, Saetre L, Olstad OK, Lyberg T. Effect of AndoSan on expression of adhesion molecules and production of reactive oxygen species in human monocytes and granulocytes in vivo. Scand J Gastroenterol. 2012 Sep;47(8-9):984-92. doi: 10.3109/00365521.2012.660544. Epub 2012 May 8.
PubMed 22564240Forland DT, Johnson E, Saetre L, Lyberg T, Lygren I, Hetland G. Effect of an extract based on the medicinal mushroom Agaricus blazei Murill on expression of cytokines and calprotectin in patients with ulcerative colitis and Crohn's disease. Scand J Immunol. 2011 Jan;73(1):66-75. doi: 10.1111/j.1365-3083.2010.02477.x.
PubMed 21129005Hetland G, Johnson E, Lyberg T, Kvalheim G. The Mushroom Agaricus blazei Murill Elicits Medicinal Effects on Tumor, Infection, Allergy, and Inflammation through Its Modulation of Innate Immunity and Amelioration of Th1/Th2 Imbalance and Inflammation. Adv Pharmacol Sci. 2011;2011:157015. doi: 10.1155/2011/157015. Epub 2011 Sep 6.
PubMed 21912538
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT01815411
- Acronym / sponsor ID
- Andosan-RA / 2012/1962
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, symptom score, fatigue, life quality, cytokines, mRNA expression, Quality of Life, Signs and Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Egil JohnsonUniversity, hospital or other
- Collaborators
- ImmunoPharma AS
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Mar 2013 (estimated)
- 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.
Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to significant pain, joint destruction and functional decline, and has a substantial economic impact both for sufferers and society. Although the etiology of RA is unknown, it is generally accepted that it arises from an interplay of genetic predisposition (in particular, HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g. autoantibody production), and environmental factors. The prevalence and incidence of RA in Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are 2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6). RA is also associated with significant comorbidity; the most important is premature cardiovascular disease that significantly contributes to increased mortality. Compared with the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden, and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids, traditional disease modifying antirheumatic drugs (including methotrexate) and biologic therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy). Also, a considerable portion of the patients are in need of joint replacement surgery and in need of rehabilitation.
However, the treatment opportunities are still not optimal. In a large proportion of the patients, full control of the disease is not possible due to limited effect of available therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new therapeutic alternatives to treat RA.
Since studies on healthy volunteers and IBD-patients support that the mushroom extract AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a pilot study whether this effect also was evident in patients with RA. A potential anti-inflammatory effect could prove beneficial in these seriously ill patients, who accordingly could experience less side effects (edema, granulocytopenia, diminished tissue repair) due to potential reduction number and dose of disease modifying drugs.
Detailed description
Main aim: Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) leads to a clinical, biochemical and genetical improvement in RA. The experiment will be carried out for 21 days in 15 eligible RA patients. In order to increase the scientific value of the project we will use, a as far as possible, an age matched control group of RA patients with steady medication and no intervention. The control group of 10-15 patients will be answering the same questionnaires and give the same samples of blood and feces.
Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of Andosan the effect of this therapy on:
- general blood samples (leucocytes, CRP, liver and renal function tests), including erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
- level of blood cytokines and analytes (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/ 17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB, RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in patients
- genetic expression in blood leukocytes (microarray) -number of swollen and tender joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue scale (VAS) for patient's and physician's global assessment of disease activity, life quality (SF-36 version 2), fatigue score.
Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of Andosan the effect of this therapy on:
- general blood samples (leucocytes, CRP, liver and renal function tests), including erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
- level of blood cytokines and analytes (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/ 17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB, RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in patients
- genetic expression in blood leukocytes (microarray) -number of swollen and tender joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue scale (VAS) for patient's and physician's global assessment of disease activity, life quality (SF-36 version 2), fatigue score.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mushroom extract | Experimental | Dietary Supplement: Mushroom extractThe patients are given the mushroom extract (Andosan) in doses 30 mlx2 per day for 1 days. The experimental group is selected by randomisation. |
| Control group | No intervention | –The control group is selected by randomisation. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>18 years
- Able and willing to give written informed consent, and to comply with the requirements of the study protocol.
- Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis.
- Moderate disease activity based on the clinical evaluation including DAS28-ESR (DAS28 3.2-5.1) [11, 12].
- Stable medication by disease modifying drugs (DMARDs) and systemic glucocorticosteroids for 3 months prior to the inclusion.
Key exclusion criteria (11 listed)
- Lack of cooperativity.
- Clinically significant chronic infection, including positive serology for hepatitis B or C, history of positive HIV status.
- Acute significant infection during the last 3 weeks before the inclusion. Surgery during the last 4 weeks before the inclusion, and during the study period.
- Clinically significant malignancy .
- Drug addiction
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 |
|---|---|---|
| Mushroom extractThe mushroom extract (Andosan) is given orally in doses 30 m x 2 daily for 21 days | Dietary supplement | Mushroom extract |
Primary outcome
Symptom score
Time frame: The duration of the experiment is 3 weeks (21 days)
The symptom score will be registered at day 1 prior to the patients are given Andosan for 21 days, and at day 21 after the patients have consumed Andosan daily for 21 days.
1 secondary outcome
Cytokine levels in harvested blood from the patients
Time frame: The duration of the experiment is 3 weeks (21 days)
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 6 Apr 2018.
- Background: PubMed 22564240Johnson E, Forland DT, Hetland G, Saetre L, Olstad OK, Lyberg T. Effect of AndoSan on expression of adhesion molecules and production of reactive oxygen species in human monocytes and granulocytes in vivo. Scand J Gastroenterol. 2012 Sep;47(8-9):984-92. doi: 10.3109/00365521.2012.660544. Epub 2012 May 8.
- Background: PubMed 21129005Forland DT, Johnson E, Saetre L, Lyberg T, Lygren I, Hetland G. Effect of an extract based on the medicinal mushroom Agaricus blazei Murill on expression of cytokines and calprotectin in patients with ulcerative colitis and Crohn's disease. Scand J Immunol. 2011 Jan;73(1):66-75. doi: 10.1111/j.1365-3083.2010.02477.x.
- Background: PubMed 21912538Hetland G, Johnson E, Lyberg T, Kvalheim G. The Mushroom Agaricus blazei Murill Elicits Medicinal Effects on Tumor, Infection, Allergy, and Inflammation through Its Modulation of Innate Immunity and Amelioration of Th1/Th2 Imbalance and Inflammation. Adv Pharmacol Sci. 2011;2011:157015. doi: 10.1155/2011/157015. Epub 2011 Sep 6.
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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.
Egil Johnson, Md, PhD principal investigator
Dep. of gastric- and pediatric surgery, Oslo University Hospital, Ulleval, Kirkeveien 166, 0407 Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mushroom extract in people with Rheumatoid Arthritis, run by Egil Johnson at 1 site in Norway.
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 5 inclusion and 11 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Symptom score (time frame: The duration of the experiment is 3 weeks (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815411, which also lists 3 linked publications.
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 6 Apr 2018.