Ulcerative ColitisPhase 2/3NCT01496053
Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
A Phase 2/3 study testing AndoSan and Sugar Extract in people with Ulcerative Colitis and Crohn's Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with ulcerative colitis (UC) and Crohn's disease (CD), experience clinical, biochemical and genetical improvement in their disease. A prospective randomised study comparing the mushroom extract with placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease
- What is being tested?
- AndoSan and Sugar Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2011to Jan 2016
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- moderate disease
Who cannot join
- serious disease,
- biological treatment,
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study
Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with ulcerative colitis (UC) and Crohn's disease (CD), experience clinical, biochemical and genetical improvement in their disease.
A prospective randomised study comparing the mushroom extract with placebo.
- Being tested
- AndoSan, Sugar Extract
- Keywords
- Cytokine levels in blood, Calprotectin in feces, Clinical symptom score.
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndoSanDietary supplement
AndoSan 30 ml x 2 for 21 days
Sugar ExtractDietary supplement
Sham comparator
| Study group | Role | What they receive |
|---|---|---|
| AndoSan | Active comparator | AndoSan given to IBD patients Receives: Dietary Supplement: AndoSan |
| Sugar extract | Sham comparator | Sugar extract to IBD patients Receives: Dietary Supplement: Sugar Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in biochemical blood parameters (pro-inflammatory cytokines)
Measured: 21 days
Secondary outcomes (2)
Reduction of calprotectin in feces.
Measured: 21 days
Clinical symptom score.
Measured: 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 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ImmunoPharma AS
- Responsible party
- Principal investigator, Egil Johnson, Oslo University Hospital
- Investigators
- Egil Johnson, MD. Phd, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496053
- Sponsor's protocol ID
- AbM2012-IBD
- Status last verified
- Oct 2020
- First submitted
- 15 Dec 2011
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Jul 14;11(7):e0159288. doi: 10.1371/journal.pone.0159288. eCollection 2016.
PubMed 27415795Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Mar 2;11(3):e0150191. doi: 10.1371/journal.pone.0150191. eCollection 2016.
PubMed 26933886
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study
- ClinicalTrials.gov ID
- NCT01496053
- Acronym / sponsor ID
- AbM2012-IBD
- Keywords
- Cytokine levels in blood, Calprotectin in feces, Clinical symptom score.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- ImmunoPharma AS
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Dec 2011 (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.
Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with ulcerative colitis (UC) and Crohn's disease (CD), experience clinical, biochemical and genetical improvement in their disease.
A prospective randomised study comparing the mushroom extract with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AndoSan | Active comparator | Dietary Supplement: AndoSanAndoSan given to IBD patients |
| Sugar extract | Sham comparator | Dietary Supplement: Sugar ExtractSugar extract to IBD patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- moderate disease
Key exclusion criteria (3 listed)
- serious disease,
- biological treatment,
- pregnancy.
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 |
|---|---|---|
| AndoSanAndoSan 30 ml x 2 for 21 days | Dietary supplement | AndoSan |
| Sugar ExtractSham comparator | Dietary supplement | Sugar extract |
Primary outcome
Reduction in biochemical blood parameters (pro-inflammatory cytokines)
Time frame: 21 days
2 secondary outcomes
Reduction of calprotectin in feces.
Time frame: 21 days
Clinical symptom score.
Time frame: 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 8 Oct 2020.
- Derived from this study: PubMed 27415795Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Jul 14;11(7):e0159288. doi: 10.1371/journal.pone.0159288. eCollection 2016.
- Derived from this study: PubMed 26933886Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Mar 2;11(3):e0150191. doi: 10.1371/journal.pone.0150191. eCollection 2016.
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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
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AndoSan and Sugar Extract in people with Ulcerative Colitis and Crohn's Disease, run by Oslo University Hospital 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 1 inclusion and 3 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 8 Oct 2020. 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. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in biochemical blood parameters (pro-inflammatory cytokines) (time frame: 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 NCT01496053, which also lists 2 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 8 Oct 2020.