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

This study is currently recruiting participants.
Verified December 2011 by Oslo University Hospital
Sponsor:
Collaborator:
ImmunoPharma
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01496053
First received: December 15, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Reduction in biochemical blood parameters (pro-inflammatory cytokines) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of calprotectin in feces. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Clinical symptom score. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate disease

Exclusion Criteria:

  • serious disease,
  • biological treatment,
  • pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496053

Contacts
Contact: Egil Johnson, MD. Phd 0047 47416334 uxegjo@ous-hf.no
Contact: Dag T Forland, MD. Phd 0047 90905384 uxdarl@ous-hf.no

Locations
Norway
Oslo University Hospital, Ulleval Recruiting
Oslo, Norway, 0407
Contact: Egil Johnson, MD. Phd     0047 47416334     uxegjo@ous-hf.no    
Sponsors and Collaborators
Oslo University Hospital
ImmunoPharma
Investigators
Principal Investigator: Egil Johnson, MD. Phd Oslo University Hospital Ulleval
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01496053     History of Changes
Other Study ID Numbers: AbM2012-IBD
Study First Received: December 15, 2011
Last Updated: December 20, 2011
Health Authority: Norway: Regional Ethics Commitee

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

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013