UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for safety evaluation of the test food long-term administration in human: a double-blind, randomized placebo-controlled and parallel study
Title of the study (Brief title)	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	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
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	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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
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