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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106742
First Posted: April 20, 2010
Last Update Posted: July 19, 2011
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.
Information provided by:
Oslo University Hospital
  Purpose
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.

Condition Intervention Phase
Inflammatory Bowel Disease Dietary Supplement: AndoSan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Potential Anti-inflammatory Effect of Mushroom Extract From Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • The ultimate goal is to see whether the ABM can be used as additional treatment of IBD. [ Time Frame: 12 days ]

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AndoSan, UC
AndoSan as a supplement to 10 UC patents
Dietary Supplement: AndoSan
AndoSan, 20mlx3, 12 days
Other Name: Agaricus blazei Murill
Experimental: AndoSan, CD
AndoSan as a supplement to 10 CD patients.
Dietary Supplement: AndoSan
AndoSan, 20mlx3, 12 days
Other Name: Agaricus blazei Murill

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate disease activity

Exclusion Criteria:

  • No use of Imurel (Azathioprin) or anti-TNF treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106742


Locations
Norway
Oslo University Hospital, Department of Surgery
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
  More Information

Responsible Party: MD. Dag T. Førland, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT01106742     History of Changes
Other Study ID Numbers: AbM2009-IBD
First Submitted: March 19, 2009
First Posted: April 20, 2010
Last Update Posted: July 19, 2011
Last Verified: March 2009

Keywords provided by Oslo University Hospital:
Inflammatory
AbM
IBD

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis


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