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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2011 by Oslo University Hospital.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01496053

First Posted: December 21, 2011

Last Update Posted: April 14, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

ImmunoPharma AS

Information provided by (Responsible Party):

Oslo University Hospital

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease ulcerative colitis

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:

Reduction in biochemical blood parameters (pro-inflammatory cytokines) [ Time Frame: 21 days ]

Secondary Outcome Measures:

Reduction of calprotectin in feces. [ Time Frame: 21 days ]
Clinical symptom score. [ Time Frame: 21 days ]


Estimated Enrollment:	100
Study Start Date:	December 2011
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	December 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT01496053 History of Changes
Other Study ID Numbers:	AbM2012-IBD
First Submitted:	December 15, 2011
First Posted:	December 21, 2011
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

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