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Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Oslo University Hospital.
Recruitment status was:  Recruiting
ImmunoPharma AS
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: December 15, 2011
Last updated: April 13, 2015
Last verified: December 2011

Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with ulcerative colitis (UC) and Crohn`s disease (CD), experience clinical, biochemical and genetical improvement in their disease.

A prospective randomised study comparing the mushroom extract with placebo.

Condition Intervention Phase
Ulcerative Colitis Crohn's Disease Inflammatory Bowel Disease Dietary Supplement: AndoSan Dietary Supplement: Sugar Extract Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Reduction in biochemical blood parameters (pro-inflammatory cytokines) [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • Reduction of calprotectin in feces. [ Time Frame: 21 days ]
  • Clinical symptom score. [ Time Frame: 21 days ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AndoSan
AndoSan given to IBD patients
Dietary Supplement: AndoSan
AndoSan 30 ml x 2 for 21 days
Sham Comparator: Sugar extract
Sugar extract to IBD patients
Dietary Supplement: Sugar Extract
Sham comparator


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • moderate disease

Exclusion Criteria:

  • serious disease,
  • biological treatment,
  • pregnancy.
  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 identifier: NCT01496053

Contact: Egil Johnson, MD. Phd 0047 47416334
Contact: Dag T Forland, MD. Phd 0047 90905384

Oslo University Hospital, Ulleval Recruiting
Oslo, Norway, 0407
Contact: Egil Johnson, MD. Phd    0047 47416334   
Sponsors and Collaborators
Oslo University Hospital
ImmunoPharma AS
Principal Investigator: Egil Johnson, MD. Phd Ullevaal University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Oslo University Hospital Identifier: NCT01496053     History of Changes
Other Study ID Numbers: AbM2012-IBD
Study First Received: December 15, 2011
Last Updated: April 13, 2015

Keywords provided by Oslo University Hospital:
Cytokine levels in blood
Calprotectin in feces
Clinical symptom score.

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Anti-Inflammatory Agents processed this record on September 21, 2017