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

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ClinicalTrials.gov Identifier: NCT01496053
Recruitment Status : Unknown
Verified December 2011 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : December 21, 2011
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
ImmunoPharma AS
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Disease Inflammatory Bowel Disease Dietary Supplement: AndoSan Dietary Supplement: Sugar Extract Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : December 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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

Inclusion Criteria:

  • moderate disease

Exclusion Criteria:

  • serious disease,
  • biological treatment,
  • pregnancy.

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): 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 AS
Investigators
Principal Investigator: Egil Johnson, MD. Phd Ullevaal University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01496053     History of Changes
Other Study ID Numbers: AbM2012-IBD
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: December 2011

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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Anti-Inflammatory Agents