UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study
Title of the study (Brief title)	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	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 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 Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035649