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OpenTrials
Completed

NCT Number: NCT01496053

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oslo University Hospital, Ulleval

Oslo, 0407, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate disease

Exclusion criteria

  • serious disease,
  • biological treatment,
  • pregnancy.

Treatment and study plan

AndoSan

Dietary Supplement

AndoSan 30 ml x 2 for 21 days

Sugar Extract

Dietary Supplement

Sham comparator

Primary outcomes

  1. Reduction in biochemical blood parameters (pro-inflammatory cytokines)

    Time frame: 21 days

Secondary outcomes

  1. Reduction of calprotectin in feces.

    Time frame: 21 days

  2. Clinical symptom score.

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • ImmunoPharma AS

Registry information

Official study title

Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Dec 21, 2011
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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