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Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome

Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome - Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049121
Enrollment
30
Registered
2022-10-05
Start date
2022-10-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy male/female adults

Interventions

Consume 3g of the test food every day for 6 weeks.

Sponsors

Toei Shinyaku Co.,Ltd.
Lead Sponsor
1)SheepMedical Co.,Ltd. 2)Laboratory for Immunopharmacology of Microbial Products, Tokyo University of Pharmacy and Life Sciences
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Males and females aged more than or equal to 20, and less than 60 when obtaining the consent.

Exclusion criteria

Exclusion criteria: 1)Subjects who are regularly consuming food or supplement containing beta-glucan which is the active ingredient of test food. 2)Subjects under treatment which would affects the trial results. 3) Subjects who do not carry out the inspection including collecting saliva and stool samples under the test rule. 4) Subjects with chronic diarrhea symptoms. 5) Subjects who have current medical history/anamnesis of severe diabetes, hepatic, renal, hypertension, cardiac, hepatic, glucose tolerance diseases. 6)Subjects who would be allergic to test foods. 7)Subjects who want to pregnancy, pregnant, possibly pregnant, or lactating women. 8)Subjects who are participating or have been participated to other clinical tests with specific medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent. 9)Subjects who take excessive alcohol or subjects with irregular dietary habits. 10)Subjects who have a plan or who have taken antibiotics within 3 months prior to the trial. 11)Subjects who have a plan or who have taken medication which would affect the trial result (e.g. drugs for intestinal disorder, and laxative) within 2 weeks prior to the trial. 12)Subjects who have removed tonsils and/or appendix. 13)Subjects who have received the surgery which would affect the trial result (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent. 14)Subjects who would encounter a dramatic change in their living environment (e.g. relocation, job-changing). 15)Others who have been determined ineligible by principal investigator or cooperating institution.

Design outcomes

Primary

MeasureTime frame
Intestinal microbiome

Secondary

MeasureTime frame
1.Oral microbiome 2.Defecation status 3.Body weight, BMI, Waist size 4.SF36v2 Japanese version

Countries

Japan

Contacts

Public ContactAkitomo Motoi

Toei Shinyaku Co.,Ltd. President

akitomo-motoi@toeishinyaku.com+81-422-26-7310

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026