Back to resultsAgaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
AndoSan
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Inflammatory, AbM, IBD
Eligibility Criteria
Inclusion Criteria:
- Moderate disease activity
Exclusion Criteria:
- No use of Imurel (Azathioprin) or anti-TNF treatment
Sites / Locations
- Oslo University Hospital, Department of Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AndoSan, UC
AndoSan, CD
Arm Description
AndoSan as a supplement to 10 UC patents
AndoSan as a supplement to 10 CD patients.
Outcomes
Primary Outcome Measures
The ultimate goal is to see whether the ABM can be used as additional treatment of IBD.
Secondary Outcome Measures
Full Information
NCT ID
NCT01106742
First Posted
March 19, 2009
Last Updated
July 18, 2011
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01106742
Brief Title
Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
Official Title
Potential Anti-inflammatory Effect of Mushroom Extract From Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Inflammatory, AbM, IBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AndoSan, UC
Arm Type
Experimental
Arm Description
AndoSan as a supplement to 10 UC patents
Arm Title
AndoSan, CD
Arm Type
Experimental
Arm Description
AndoSan as a supplement to 10 CD patients.
Intervention Type
Dietary Supplement
Intervention Name(s)
AndoSan
Other Intervention Name(s)
Agaricus blazei Murill
Intervention Description
AndoSan, 20mlx3, 12 days
Primary Outcome Measure Information:
Title
The ultimate goal is to see whether the ABM can be used as additional treatment of IBD.
Time Frame
12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate disease activity
Exclusion Criteria:
No use of Imurel (Azathioprin) or anti-TNF treatment
Facility Information:
Facility Name
Oslo University Hospital, Department of Surgery
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
We'll reach out to this number within 24 hrs