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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042292
Receipt No. R000048281
Scientific Title Effect of "Tonyu Guruto" on defecation
Date of disclosure of the study information 2021/05/07
Last modified on 2021/05/06

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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

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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