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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate disease activity

Exclusion Criteria:

  • No use of Imurel (Azathioprin) or anti-TNF treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106742

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

No publications provided

Responsible Party: MD. Dag T. Førland, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT01106742     History of Changes
Other Study ID Numbers: AbM2009-IBD
Study First Received: March 19, 2009
Last Updated: July 18, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Inflammatory
AbM
IBD

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

ClinicalTrials.gov processed this record on October 02, 2014