UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037314 |
|---|---|
| Receipt number | R000042416 |
| Scientific Title | Evaluation study for influence of intake of RIW-1 on improvement in intestinal environment |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2020/01/09 17:05:25 |
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Basic information
Public title
Evaluation study for influence of intake of RIW-1 on improvement in intestinal environment
Acronym
Evaluation study for influence of intake of RIW-1 on improvement in intestinal environment
Scientific Title
Evaluation study for influence of intake of RIW-1 on improvement in intestinal environment
Scientific Title:Acronym
Evaluation study for influence of intake of RIW-1 on improvement in intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of intake of supplements in improving intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal bacterial flora
Key secondary outcomes
Stool composition
Questionnaire on defecation(distention, exhaust gas amount, defecation frequency, defecation pain, defecation quantity, defecation feeling, stool form, stool smell)
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of high-dose test food for 4 weeks
Interventions/Control_2
Daily intake of low-dose test food for 4 weeks
Interventions/Control_3
Daily intake of placebo food for 4 weeks
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Healthy Japanese females aged 30 to 49 years old
2) Subjects who have less habit of eating yogurt (2 times a week or less)
3) Subjects who have less habit of drinking lactic acid bacteria beverage (once a week or less)
4) Subjects who have no habit of taking in fiber-fortified foods, oligosaccharides or lactic acid bacteria Yeast supplements
5) Subjects with defecation frequency 4 to 8 times per week
6) Subjects with hard to normal form of stool (Bristol Stool Scale 2 to 4)
7) Subjects who do not alternate constipation and diarrhea
8) Subjects who can collect their own stool specimens and keep them in their own freezer at home until submission
9) Subjects who have periodic menstruation
10) Subjects with BMI less than 25
Key exclusion criteria
1) Subjects who participate in other clinical trials
2) Subjects who are pregnant, lactating or possibly pregnant
3) Subjects with menopause
4) Subjects with tendency of diarrhea or loose stool
5) Subjects who regularly use antiflatulents, stomach medicines, gastrointestinal drugs, laxatives or female hormones
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality and Innovations, Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2019 | Year | 10 | Month | 31 | 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
99
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 | 06 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 26 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042416
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| Registered date | File name |
| Research case data | |
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