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

Primary Purpose

Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
AndoSan
Sugar Extract
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Cytokine levels in blood, Calprotectin in feces, Clinical symptom score.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate disease

Exclusion Criteria:

  • serious disease,
  • biological treatment,
  • pregnancy.

Sites / Locations

  • Oslo University Hospital, Ulleval

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

AndoSan

Sugar extract

Arm Description

AndoSan given to IBD patients

Sugar extract to IBD patients

Outcomes

Primary Outcome Measures

Reduction in biochemical blood parameters (pro-inflammatory cytokines)

Secondary Outcome Measures

Reduction of calprotectin in feces.
Clinical symptom score.

Full Information

First Posted
December 15, 2011
Last Updated
October 5, 2020
Sponsor
Oslo University Hospital
Collaborators
ImmunoPharma AS
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1. Study Identification

Unique Protocol Identification Number
NCT01496053
Brief Title
Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
Official Title
Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
ImmunoPharma AS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease
Keywords
Cytokine levels in blood, Calprotectin in feces, Clinical symptom score.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AndoSan
Arm Type
Active Comparator
Arm Description
AndoSan given to IBD patients
Arm Title
Sugar extract
Arm Type
Sham Comparator
Arm Description
Sugar extract to IBD patients
Intervention Type
Dietary Supplement
Intervention Name(s)
AndoSan
Intervention Description
AndoSan 30 ml x 2 for 21 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar Extract
Intervention Description
Sham comparator
Primary Outcome Measure Information:
Title
Reduction in biochemical blood parameters (pro-inflammatory cytokines)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Reduction of calprotectin in feces.
Time Frame
21 days
Title
Clinical symptom score.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate disease Exclusion Criteria: serious disease, biological treatment, pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egil Johnson, MD. Phd
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Ulleval
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27415795
Citation
Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Jul 14;11(7):e0159288. doi: 10.1371/journal.pone.0159288. eCollection 2016.
Results Reference
derived
PubMed Identifier
26933886
Citation
Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Mar 2;11(3):e0150191. doi: 10.1371/journal.pone.0150191. eCollection 2016.
Results Reference
derived

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

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