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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01496053
Date of registration: 15/12/2011
Prospective Registration: No
Primary sponsor: Oslo University Hospital
Public title: Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
Scientific title: Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study
Date of first enrolment: December 2011
Target sample size: 100
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01496053
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  Phase 2/Phase 3
Countries of recruitment
Norway
Contacts
Name:     Egil Johnson, MD. Phd
Address: 
Telephone:
Email:
Affiliation:  Ullevaal University Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- moderate disease

Exclusion Criteria:

- serious disease,

- biological treatment,

- pregnancy.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Intervention(s)
Dietary Supplement: AndoSan
Dietary Supplement: Sugar Extract
Primary Outcome(s)
Reduction in biochemical blood parameters (pro-inflammatory cytokines) [Time Frame: 21 days]
Secondary Outcome(s)
Reduction of calprotectin in feces. [Time Frame: 21 days]
Clinical symptom score. [Time Frame: 21 days]
Secondary ID(s)
AbM2012-IBD
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
ImmunoPharma AS
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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