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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
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
  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:


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
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: 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:
Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Intestinal Diseases
Colitis
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014