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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01496053
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
ImmunoPharma AS
Information provided by (Responsible Party):
Egil Johnson, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE December 15, 2011
First Posted Date  ICMJE December 21, 2011
Last Update Posted Date October 8, 2020
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
Reduction in biochemical blood parameters (pro-inflammatory cytokines) [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
  • Reduction of calprotectin in feces. [ Time Frame: 21 days ]
  • Clinical symptom score. [ Time Frame: 21 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Crohn's Disease
  • Inflammatory Bowel Disease
Intervention  ICMJE
  • Dietary Supplement: AndoSan
    AndoSan 30 ml x 2 for 21 days
  • Dietary Supplement: Sugar Extract
    Sham comparator
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • moderate disease

Exclusion Criteria:

  • serious disease,
  • biological treatment,
  • pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01496053
Other Study ID Numbers  ICMJE AbM2012-IBD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Egil Johnson, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE ImmunoPharma AS
Investigators  ICMJE
Principal Investigator: Egil Johnson, MD. Phd Ullevaal University Hospital
PRS Account Oslo University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP