Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedOctober 8, 2020
October 1, 2020
4 years
December 15, 2011
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in biochemical blood parameters (pro-inflammatory cytokines)
21 days
Secondary Outcomes (2)
Reduction of calprotectin in feces.
21 days
Clinical symptom score.
21 days
Study Arms (2)
AndoSan
ACTIVE COMPARATORAndoSan given to IBD patients
Sugar extract
SHAM COMPARATORSugar extract to IBD patients
Interventions
Eligibility Criteria
You may qualify if:
- moderate disease
You may not qualify if:
- serious disease,
- biological treatment,
- pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- ImmunoPharma AScollaborator
Study Sites (1)
Oslo University Hospital, Ulleval
Oslo, 0407, Norway
Related Publications (2)
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.
PMID: 27415795DERIVEDTherkelsen 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.
PMID: 26933886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Egil Johnson, MD. Phd
Ullevaal University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Phd
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 21, 2011
Study Start
December 1, 2011
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
October 8, 2020
Record last verified: 2020-10