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

NCT ID: NCT01106742

Last Updated: 2011-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AndoSan, UC

AndoSan as a supplement to 10 UC patents

Group Type EXPERIMENTAL

AndoSan

Intervention Type DIETARY_SUPPLEMENT

AndoSan, 20mlx3, 12 days

AndoSan, CD

AndoSan as a supplement to 10 CD patients.

Group Type EXPERIMENTAL

AndoSan

Intervention Type DIETARY_SUPPLEMENT

AndoSan, 20mlx3, 12 days

Interventions

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AndoSan

AndoSan, 20mlx3, 12 days

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Agaricus blazei Murill

Eligibility Criteria

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Inclusion Criteria

* Moderate disease activity

Exclusion Criteria

* No use of Imurel (Azathioprin) or anti-TNF treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ullevaal University Hospital

Locations

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Oslo University Hospital, Department of Surgery

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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AbM2009-IBD

Identifier Type: -

Identifier Source: org_study_id

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