UMIN-CTR Clinical Trial

Basic information
Public title	Effect of "Tonyu Guruto" on defecation
Acronym	Effect of "Tonyu Guruto" on defecation
Scientific Title	Effect of "Tonyu Guruto" on defecation
Scientific Title:Acronym	Effect of "Tonyu Guruto" on defecation
Region	Japan

Condition
Condition	Subjects with a tendency for constipation
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Soymilk fermented with lactic acid bacteria is used in an experimental diet to examine whether intake affects to defecation frequency.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stool quantity(2 weeks after intake)
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Soymilk fermented with lactic acid bacteria(2 weeks intake)
Interventions/Control_2	Placebo(Soymilk fermented without lactic acid bacteria)(2 weeks intake)
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Males and femaes from 20 to 50 years of age (2)Subjects whose defecation frequency two to five times a week (3)Subjects who usually has three meals a day
Key exclusion criteria	(1)Subjects who digestive tract disease or treatment (2)Subjects who has serious medical history or who had digestive tract resection surgery (3)Subjects who are pregnant or lactating (4)Subjects who routinely use medicine which affect to result of this study (5)Subjects who regularly take yogurt or similar products (6)Subjects who have allergic to soybean (7)Subjects who routinely use supplements, FOSHU, and/or health food which affect to result of this study (8)Subjects who has heavy use of alcohol or excessive smokes (9)Subjects who are judged unsuitable for this study by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Hoshino
Organization	Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name	General Medicine Clinical Departments Internal Medicine Respiratory Medicine Allergy
Zip code	003-0011
Address	7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido 003-0011, Japan
TEL	011-868-2711
Email	shiroishi@jikkai.or.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name Abe
Organization	Medical Corporation Jikokai
Division name	Clinical Trial Division
Zip code	003-0011
Address	7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido 003-0011, Japan
TEL	011-868-2711
Homepage URL
Email	n-abe@medi-ate.jp

Sponsor
Institute	MARUSAN-AI Co.,Ltd
Institute
Department

Funding Source
Organization	MARUSAN-AI Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukuzumi Internal Medicine Clinic IRB
Address	2-2-5 chou-2 jo, Fukuzumi, Shiroishi-ku, Sapporo, Hokkaido 062-0042, Japan
Tel	011-836-3531
Email	fukui@mediks.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	2021 Year 05 Month 07 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	Completed
Date of protocol fixation	2020 Year 10 Month 15 Day
Date of IRB	2020 Year 10 Month 23 Day
Anticipated trial start date	2020 Year 11 Month 16 Day
Last follow-up date	2021 Year 03 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 10 Month 30 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048281