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

Phase 2

Completed

• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease; Crohn's Disease
• Interventions: Dietary Supplement: AndoSan; Dietary Supplement: Sugar Extract

• Registration Number: NCT01496053
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• moderate disease

Exclusion Criteria

• serious disease,
• biological treatment,
• pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AndoSan	AndoSan	AndoSan given to IBD patients
Sugar extract	Sugar Extract	Sugar extract to IBD patients

Primary Outcome Measures

Name	Time	Method
Reduction in biochemical blood parameters (pro-inflammatory cytokines)	21 days

Secondary Outcome Measures

Name	Time	Method
Reduction of calprotectin in feces.	21 days
Clinical symptom score.	21 days

Trial Locations

Locations (1)

Oslo University Hospital, Ulleval; 🇳🇴 Oslo, Norway