UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031218 |
|---|---|
| Receipt number | R000035649 |
| Scientific Title | The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2018/07/19 09:19:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study
Acronym
The verification study for safety evaluation of excessive the test food ingestion in humans
Scientific Title
The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study
Scientific Title:Acronym
The verification study for safety evaluation of excessive the test food ingestion in humans
Region
| Japan |
Condition
Condition
Healthy Japanese adult people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the safety of overdose the test food, containing Bacillus subtilis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Physical examination
2. Urinalysis
3. Blood test
*1-3 Perform the test at screening and examination before consuming and at 2, and 4 weeks after ingestion
Key secondary outcomes
Simple measurement of bone mineral density
*Perform the test at screening and examination before consuming and at 2, and 4 weeks after ingestion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 4 weeks
Test materials: Tablets containing Bacillus subtilis
Dose: 18 tablets per day
Administration: Take the test tablets with water multiple times per day. Do not chew tablets.
* Daily dose must be taken within the day.
Interventions/Control_2
Duration: 4 weeks
Test materials: Placebo
Dose: 18 tablets per day
Administration: Take the test tablets with water multiple times per day. Do not chew tablets.
* Daily dose must be taken within the day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult people
2. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria
1. A medical history of malignant tumor, heart failure or myocardial infarction
2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome, osteoporosis, or any other chronic diseases
3. Subjects who daily consume "Foods for Specified Health Uses" or "Foods with Functional Claims"
4. Currently taking medications (include herbal medicines) and supplements
*Particularly taking warfarin
5. Subjects who are allergic to medications and/or products related to the study substance
*Particularly soybeans, natto allergy
6. Subjects who have lactose intolerance
7. Subjects who are pregnant, lactation, and planning to become pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ASAHI CALPIS WELLNESS CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 09 | 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
| 2018 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035649
