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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028195
Receipt No. R000032252
Scientific Title The verification study for safety evaluation of the test food long-term administration in human: a double-blind, randomized placebo-controlled and parallel study
Date of disclosure of the study information 2017/07/12
Last modified on 2018/07/05

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Basic information
Public title The verification study for safety evaluation of the test food long-term administration in human: a double-blind, randomized placebo-controlled and parallel study
Acronym The verification study for safety evaluation of the test food long-term administration in human
Scientific Title The verification study for safety evaluation of the test food long-term administration in human: a double-blind, randomized placebo-controlled and parallel study
Scientific Title:Acronym The verification study for safety evaluation of the test food long-term administration in human
Region
Japan

Condition
Condition Healthy Japanese adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the safety of long-term administration of 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. Body measuring / Physical examination
2. Urinalysis
3. Blood test
4. Questionnaire (the Likert scale)
5. Bowel movement diary

*1-4 Perform the test at 0 week and at 4, 8, and 12 weeks after ingestion
*5 Record when having the defecation from a week before screening test to a day before the final test
Key secondary outcomes

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: 12 weeks
Test materials: Tablets containing Bacillus subtilis
Dose: 3 tablets per day
Administration: Take 3 tablets after breakfast with water. Do not chew tablets.
* Daily dose must be taken within the day. If you forget take tablets, take them as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test materials: Placebo
Dose: 3 tablets per day
Administration: Take 3 tablets after breakfast with water. Do not chew tablets.
* Daily dose must be taken within the day. If you forget take tablets, take them as soon as you remember 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 adults

2. Subjects who are judged as eligible to participate in the study by the principal investigator

3. Among the subjects who passed 2., select the participants according to the following rules
20s: 2 or more male and female, 30s: 2 or more male and female, 40s: 4 or more male and female, 50s: 4 or more male and female, 60 or more to less than 80 years old: 6 or more male and female

4. Select the participants as equal as possible from subjects who have loose stool *1, constipated subjects *2, and subjects who have normal stool *3

*1 Subjects whose weekly average of bristol scale score is more than 5
*2 Subjects who defecate 2 to 4 times per week
*3 Subjects whose weekly average of bristol scale score is less than 5 and defecate more than 4 times per week
Key exclusion criteria 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome (IBS) or other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Currently taking medicines (include herbal medicines) and supplements
*Particularly taking warfarin

5. Subjects who are allergic to medicines and/or the test food related products
*Particularly soybeans, natto allergy

6. Subjects who have lactose intolerance

7. Subjects who are pregnant, breast-feeding, and plan to become a 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 principal investigator
Target sample size 36

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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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 Medical Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Medical Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Kanzato H, Tsuda R, Nadaoka I, Yasue M, Suzuki N, Takara T. Safety Evaluation of Long-term Administration of Bacillus subtilis C-3102-containing Food in Healthy Subjects-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-. Jpn Pharmacol Ther 2018; 46(5): 883-896
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
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 13 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
2017 Year 07 Month 12 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032252

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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