UMIN-CTR Clinical Trial

Basic information
Public title	A study for safety evaluation of excessive intake of Lactic acid bacterium-powder
Acronym	Safety evaluation of excessive intake of Lactic acid bacterium-powder
Scientific Title	A study for safety evaluation of excessive intake of Lactic acid bacterium-powder
Scientific Title:Acronym	Safety evaluation of excessive intake of Lactic acid bacterium-powder
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of the excessive intake of Lactic acid bacterium-powder
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event and side effect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of Lactic acid bacterium-powder for 4 weeks
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Subjects aged more than 20 years, less than 65 years. 2)Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Key exclusion criteria	1)Subjects who have a history of serious illness. 2)Subjects who are under treatment with medication for lifestyle-related disease (diabetes, hypertension, dyslipidemia). 3)Subjects who have digestive tract diseases that affect digestion and absorption, and have had a history of gastrointestinal surgery (excluding appendicitis). 4)Subjects who have a medical history of serious allergy to medicine, food and pollen. 5)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study. 6)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 7)Subjects who are planning to participate in other clinical studies. 8)Subjects who are judged unsuitable for participating in this study by the principal investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Tokushima
Organization	Maebashi North Hospital
Division name	Director
Zip code	371-0054
Address	692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL	027-235-3333
Email	sagawa@mc-connect.co.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel	027-212-5608
Email	sagawa@mc-connect.co.jp

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 前橋北病院（群馬県）/ Maebashi North Hospital (Gunma)

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 21 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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 12 Day
Date of IRB	2021 Year 02 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 22 Day
Last follow-up date	2021 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 19 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049523

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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