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

NCT ID: NCT01496053

Last Updated: 2020-10-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis Crohn's Disease Inflammatory Bowel Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AndoSan

AndoSan given to IBD patients

Group Type ACTIVE_COMPARATOR

AndoSan

Intervention Type DIETARY_SUPPLEMENT

AndoSan 30 ml x 2 for 21 days

Sugar extract

Sugar extract to IBD patients

Group Type SHAM_COMPARATOR

Sugar Extract

Intervention Type DIETARY_SUPPLEMENT

Sham comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AndoSan

AndoSan 30 ml x 2 for 21 days

Intervention Type DIETARY_SUPPLEMENT

Sugar Extract

Sham comparator

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* moderate disease

Exclusion Criteria

* serious disease,
* biological treatment,
* pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ImmunoPharma AS

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Egil Johnson

MD, Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Egil Johnson, MD. Phd

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oslo University Hospital, Ulleval

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Jul 14;11(7):e0159288. doi: 10.1371/journal.pone.0159288. eCollection 2016.

Reference Type DERIVED
PMID: 27415795 (View on PubMed)

Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Mar 2;11(3):e0150191. doi: 10.1371/journal.pone.0150191. eCollection 2016.

Reference Type DERIVED
PMID: 26933886 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AbM2012-IBD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dried Chicory Root in IBD
NCT06016322 UNKNOWN NA