UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036586 |
|---|---|
| Receipt number | R000041635 |
| Scientific Title | Effect of "Tonyu Guruto" on defecation |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/10/22 10:47:33 |
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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
Key secondary outcomes
Defecation frequency, fecal shape, fecal color, pH and water content in feces,organic acid content in feces, ammonia content in feces, gut microbiota
Base
Study type
Interventional
Study design
Basic design
Cross-over
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)-washout(2 weeks)-placebo(Soymilk fermented without lactic acid bacteria)(2 weeks intake)
Interventions/Control_2
Placebo(Soymilk fermented without lactic acid bacteria)(2 weeks intake)-washout(2 weeks)-Soymilk fermented with 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
80
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
shiroishi@jikkai.or.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Suzuki |
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
suzuki-jikoukai@e-mail.jp
Sponsor or person
Institute
MARUSAN-AI Co.,Ltd
Institute
Department
Personal name
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
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
医療法人社団 慈昂会 白石内科クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
80
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
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 23 | Day |
Last modified on
| 2020 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041635
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
