UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049121 |
|---|---|
| Receipt number | R000055901 |
| Scientific Title | Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome |
| Date of disclosure of the study information | 2022/10/05 |
| Last modified on | 2023/04/12 15:14:41 |
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Basic information
Public title
Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome
Acronym
Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome
Scientific Title
Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome
Scientific Title:Acronym
Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of the test-food consumed for 6 weeks on oral and intestinal microbiome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal microbiome
Key secondary outcomes
1.Oral microbiome
2.Defecation status
3.Body weight, BMI, Waist size
4.SF36v2 Japanese version
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume 3g of the test food every day for 6 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Males and females aged more than or equal to 20, and less than 60 when obtaining the consent.
Key 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akitomo |
| Middle name | |
| Last name | Motoi |
Organization
Toei Shinyaku Co.,Ltd.
Division name
President
Zip code
181-0013
Address
1-11-23 Shimorenjaku, Mitaka, Tokyo, Japan
TEL
+81-422-26-7310
akitomo-motoi@toeishinyaku.com
Public contact
Name of contact person
| 1st name | Akitomo |
| Middle name | |
| Last name | Motoi |
Organization
Toei Shinyaku Co.,Ltd.
Division name
President
Zip code
181-0013
Address
1-11-23 Shimorenjaku, Mitaka, Tokyo, Japan
TEL
+81-422-26-7310
Homepage URL
akitomo-motoi@toeishinyaku.com
Sponsor or person
Institute
Toei Shinyaku Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toei Shinyaku Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1)SheepMedical Co.,Ltd.
2)Laboratory for Immunopharmacology of Microbial Products, Tokyo University of Pharmacy and Life Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Health Preventive Medicine Foundation
Address
1-25-1 Asahi cho, Atsugi, Kanagawa, Japan
Tel
+81-46-277-2005
info@h-p-m.org
Secondary IDs
Secondary IDs
YES
Study ID_1
8
Org. issuing International ID_1
Institutional Review Board of Health Preventive Medicine Foundation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055901
