UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for loose stools improvement effect by Bacillus subtilis: a double-blind, randomized placebo-controlled and parallel study
Title of the study (Brief title)	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	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
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	Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funｄer(s)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026027