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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 : Completed
First Posted : December 21, 2011
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
ImmunoPharma AS
Information provided by (Responsible Party):
Egil Johnson, Oslo University Hospital

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Norway
Oslo University Hospital, Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
ImmunoPharma AS
Investigators
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Principal Investigator: Egil Johnson, MD. Phd Ullevaal University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Egil Johnson, MD, Phd, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01496053    
Other Study ID Numbers: AbM2012-IBD
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by Egil Johnson, Oslo University Hospital:
Cytokine levels in blood
Calprotectin in feces
Clinical symptom score.
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases