Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

July 18, 2011 updated by: Ullevaal University Hospital

Potential Anti-inflammatory Effect of Mushroom Extract From Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill) based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy volunteers after 12 days consumption, the aim in this study is to investigate whether same effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal inflammation will be measured in blood and feces of these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate disease activity

Exclusion Criteria:

  • No use of Imurel (Azathioprin) or anti-TNF treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AndoSan, UC
AndoSan as a supplement to 10 UC patents
Dietary supplement: AndoSan
AndoSan, 20mlx3, 12 days
Other Names:
  • Agaricus blazei Murill
EXPERIMENTAL: AndoSan, CD
AndoSan as a supplement to 10 CD patients.
Dietary supplement: AndoSan
AndoSan, 20mlx3, 12 days
Other Names:
  • Agaricus blazei Murill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ultimate goal is to see whether the ABM can be used as additional treatment of IBD.
Time Frame: 12 days
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

April 19, 2010

First Posted (ESTIMATE)

April 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AbM2009-IBD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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