Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
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ClinicalTrials.gov Identifier: NCT01496053 |
Recruitment Status :
Completed
First Posted : December 21, 2011
Last Update Posted : October 8, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis Crohn's Disease Inflammatory Bowel Disease | Dietary Supplement: AndoSan Dietary Supplement: Sugar Extract | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
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Active Comparator: AndoSan
AndoSan given to IBD patients
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Dietary Supplement: AndoSan
AndoSan 30 ml x 2 for 21 days |
Sham Comparator: Sugar extract
Sugar extract to IBD patients
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Dietary Supplement: Sugar Extract
Sham comparator |
- Reduction in biochemical blood parameters (pro-inflammatory cytokines) [ Time Frame: 21 days ]
- Reduction of calprotectin in feces. [ Time Frame: 21 days ]
- Clinical symptom score. [ Time Frame: 21 days ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- moderate disease
Exclusion Criteria:
- serious disease,
- biological treatment,
- pregnancy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496053
Norway | |
Oslo University Hospital, Ulleval | |
Oslo, Norway, 0407 |
Principal Investigator: | Egil Johnson, MD. Phd | Ullevaal University Hospital |
Responsible Party: | Egil Johnson, MD, Phd, Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT01496053 |
Other Study ID Numbers: |
AbM2012-IBD |
First Posted: | December 21, 2011 Key Record Dates |
Last Update Posted: | October 8, 2020 |
Last Verified: | October 2020 |
Cytokine levels in blood Calprotectin in feces Clinical symptom score. |
Crohn Disease Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Colitis Colonic Diseases |