UMIN-CTR Clinical Trial

Basic information
Public title	Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Acronym	Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Scientific Title	Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Scientific Title:Acronym	Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the intestinal environment improving effect by intake of lactic acid bacteria producing extract for 4 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Creatinine-corrected urinary indoxyl sulfate levels 4 weeks after continuous intake
Key secondary outcomes	Questionnaire(Defection status, physical condition, etc) 4 weeks after continuous intake

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 10ml of lactic acid bacteria producing extract daily 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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese women who are 30 years old or more and under 50 years old 3.Persons who have constipation tendencies from the preliminary survey questionnaire 4.The top 30 urinary indoxyl sulfate levels at screening
Key exclusion criteria	1.Persons who have chronic illness 2.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding 3.Persons who are taking medications that affect the intestinal environment, such as intestinal medicines, laxatives, and antibiotics 4.Persons who are taking dietary fiber or lactic acid bacteria supplements that improve the intestinal environment 5.Persons who are allergic to soy 6.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Sasuga
Organization	B&S corporation Co., Ltd.
Division name	Production & Development Division
Zip code	102-0073
Address	4-1-28 Kudankita, Chiyoda-ku, Tokyo, JAPAN
TEL	03-3288-0115
Email	y-sasuga@bandscorp.jp

Public contact
Name of contact person	1st name Miho Middle name Last name Matsumoto
Organization	Healthcare Systems Co., Ltd.
Division name	Sales Planning Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	050-3640-3595
Homepage URL
Email	matsumoto@hc-sys.jp

Sponsor
Institute	B&S corporation Co., Ltd.
Institute
Department

Funding Source
Organization	B&S corporation Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Medical and Dental University Healthcare Systems Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	kakehashi@hc-sys.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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 28 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	30
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	2020 Year 01 Month 24 Day
Date of IRB	2020 Year 01 Month 24 Day
Anticipated trial start date	2020 Year 02 Month 06 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 28 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044790