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Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01106742
First received: March 19, 2009
Last updated: July 18, 2011
Last verified: March 2009

March 19, 2009
July 18, 2011
March 2009
July 2011   (final data collection date for primary outcome measure)
The ultimate goal is to see whether the ABM can be used as additional treatment of IBD. [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01106742 on ClinicalTrials.gov Archive Site
Not Provided
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Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
Potential Anti-inflammatory Effect of Mushroom Extract From Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill) based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy volunteers after 12 days consumption, the aim in this study is to investigate whether same effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal inflammation will be measured in blood and feces of these patients.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Inflammatory Bowel Disease
Dietary Supplement: AndoSan
AndoSan, 20mlx3, 12 days
Other Name: Agaricus blazei Murill
  • Experimental: AndoSan, UC
    AndoSan as a supplement to 10 UC patents
    Intervention: Dietary Supplement: AndoSan
  • Experimental: AndoSan, CD
    AndoSan as a supplement to 10 CD patients.
    Intervention: Dietary Supplement: AndoSan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate disease activity

Exclusion Criteria:

  • No use of Imurel (Azathioprin) or anti-TNF treatment
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01106742
AbM2009-IBD
Yes
MD. Dag T. Førland, Ullevaal University Hospital
Ullevaal University Hospital
Not Provided
Not Provided
Oslo University Hospital
March 2009

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