Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)

• ClinicalTrials.gov Identifier: NCT01496053
• Recruitment Status: Completed
• First Posted: December 21, 2011
• Last Update Posted: October 8, 2020
• Sponsor: Oslo University Hospital
• Collaborator: ImmunoPharma AS
• Information provided by (Responsible Party): Egil Johnson, Oslo University Hospital

Tracking Information

• First Submitted Date: December 15, 2011
• First Posted Date: December 21, 2011
• Last Update Posted Date: October 8, 2020
• Study Start Date: December 2011
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 20, 2011): Reduction in biochemical blood parameters (pro-inflammatory cytokines) [ Time Frame: 21 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 20, 2011)

• Reduction of calprotectin in feces. [ Time Frame: 21 days ]
• Clinical symptom score. [ Time Frame: 21 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
• Official Title: Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Ulcerative Colitis
• Crohn's Disease
• Inflammatory Bowel Disease

Intervention

• Dietary Supplement: AndoSan
  AndoSan 30 ml x 2 for 21 days
• Dietary Supplement: Sugar Extract
  Sham comparator

Study Arms

• Active Comparator: AndoSan
  AndoSan given to IBD patients
  Intervention: Dietary Supplement: AndoSan
• Sham Comparator: Sugar extract
  Sugar extract to IBD patients
  Intervention: Dietary Supplement: Sugar Extract

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.
• Therkelsen 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 20, 2011): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2016
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• moderate disease

Exclusion Criteria:

• serious disease,
• biological treatment,
• pregnancy.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT01496053
• Other Study ID Numbers: AbM2012-IBD
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Egil Johnson, Oslo University Hospital
• Study Sponsor: Oslo University Hospital
• Collaborators: ImmunoPharma AS

Investigators

• Principal Investigator: Egil Johnson, MD. Phd; Ullevaal University Hospital

• PRS Account: Oslo University Hospital
• Verification Date: October 2020