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

Phase 2

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Dietary Supplement: AndoSan

• Registration Number: NCT01106742
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2009-03
• Study Start: 2009-03
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-18
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Moderate disease activity

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AndoSan, UC	AndoSan	AndoSan as a supplement to 10 UC patents
AndoSan, CD	AndoSan	AndoSan as a supplement to 10 CD patients.

Primary Outcome Measures

Name	Time	Method
The ultimate goal is to see whether the ABM can be used as additional treatment of IBD.	12 days

Trial Locations

Locations (1)

Oslo University Hospital, Department of Surgery; 🇳🇴 Oslo, Norway