UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022583 |
|---|---|
| Receipt number | R000026027 |
| Scientific Title | The verification study for loose stools improvement effect by Bacillus subtilis: a double-blind, randomized placebo-controlled and parallel study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/01/30 18:49:36 |
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Basic information
Public title
The verification study for loose stools improvement effect by Bacillus subtilis: a double-blind, randomized placebo-controlled and parallel study
Acronym
The verification study for loose stools improvement effect by Bacillus subtilis
Scientific Title
The verification study for loose stools improvement effect by Bacillus subtilis: a double-blind, randomized placebo-controlled and parallel study
Scientific Title:Acronym
The verification study for loose stools improvement effect by Bacillus subtilis
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate loose stools improvement by ingestion of Bacillus subtilis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Bristol scale
*1 Perform the test every day.
2. Water content in feces
*2 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
3. Gastrointestinal Symptom Rating Scale (GSRS)
*3 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
Key secondary outcomes
1. Bowel in bacterial flora analysis
*1 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
2. Organic acids
*2 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
3. Decay products
*3 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
4. Short Form-8 (SF-8)
*4 Perform the test at 0 week and 4 and 8 weeks after the 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 8 weeks
Test material: Tablets containing Bacillus subtilis spores
Dose: Take 3 tablets a day
*2.2X109CFU/day
Administration: Once a day
Interventions/Control_2
Duration: 8 weeks
Test material: placebo
Dose: Take 3 tablets a day
Administration: Once a 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adults
2. Become aware of loose stools
Key exclusion criteria
1. At least one previous medical history 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. Currently taking medicines (include herbal medicines), supplements, Food for Specified Health Uses, and/or Foods with Functional Claims
*Particularly taking warfarin
4. Persons who eat natto more than 4 times per week
5. Persons who consume yogurt and/or beverages including lactic acid bacteria/bifidobacteria more than 4 times per week
6. Allergic to medicines or foods related to the test food of this trial.
*Particularly soybeans, natto allergy
7. Pregnant, lactating, or planning to get pregnant during the trial period
8. Persons who have participated by 2015, "Bacillus subtilis, loose stools better effect validation test"
9. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
10. Judged unsuitable for participating in this trial by physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO, Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
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.
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
Seishin-kai Medical Association Inc, Takara Medical 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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 03 | 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
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026027
