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NCT01106742 Clinical Trial

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

Inflammatory Bowel Disease Clinical Trial

Official title:
Potential Anti-inflammatory Effect of Mushroom Extract From Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01106742
Other study ID # AbM2009-IBD
Secondary ID
Status Completed
Phase Phase 2
First received March 19, 2009
Last updated July 18, 2011
Start date March 2009
Est. completion date July 2011

Study information
Verified date March 2009
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Moderate disease activity

Exclusion Criteria:

- No use of Imurel (Azathioprin) or anti-TNF treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• AndoSan
AndoSan, 20mlx3, 12 days

Locations
Country Name City State
Norway Oslo University Hospital, Department of Surgery Oslo

Sponsors (1)
Lead Sponsor Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary The ultimate goal is to see whether the ABM can be used as additional treatment of IBD. 12 days No
See also
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