UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033918 |
|---|---|
| Receipt number | R000038665 |
| Scientific Title | Effects of test foods on Stool Frequency andskin in Healthy Individuals: A Randomized, Double-blind Study |
| Date of disclosure of the study information | 2018/08/28 |
| Last modified on | 2021/04/16 10:27:33 |
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Basic information
Public title
Effects of test foods on Stool Frequency andskin in Healthy Individuals: A Randomized, Double-blind Study
Acronym
Effects of test foods on Stool Frequency andskin in Healthy Individuals: A Randomized, Double-blind Study
Scientific Title
Effects of test foods on Stool Frequency andskin in Healthy Individuals: A Randomized, Double-blind Study
Scientific Title:Acronym
Effects of test foods on Stool Frequency andskin in Healthy Individuals: A Randomized, Double-blind Study
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this test is to confirm the bowel improvement effect expected of fermented foods. Also, as the intestinal environment and the skin condition are considered to be closely related, we also confirm changes in the skin condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel movements after ingestion 8 week
Key secondary outcomes
intestinal flora, skin moisture, TEWL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of fermental foods
Intake period: 8week
Interventions/Control_2
Ingestion of placebo
Intake period: 8week
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Participants aged 20 to64 years
2.Infrequent bowel movements 3 to 5 movements a week
3.Persons sending regular eating habits three meals a day
4.Those who are concerned about drying of the skin as subjective symptoms
5.Person who obtains consent of voluntary participation in examination by document
Key exclusion criteria
1.Persons undergoing definitive diagnosis as constipation and chronic constipation or those who meet the following criteria of the Guideline 2017 for the treatment of chronic constipation
2. Known allergy or sensitivity to any foods
3. Participants who use any medecines or supplements
4.History of severe disease such as intestinal diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Choryo |
| Middle name | |
| Last name | Uema |
Organization
Ishikawa Shuzojo Co., Ltd
Division name
Manufacturing division
Zip code
903-0103
Address
Konaha 1438-1, Nishihara-cho, Okinawa
TEL
098-945-3515
uemac@kamejikomi.com
Public contact
Name of contact person
| 1st name | Choryo |
| Middle name | |
| Last name | Uema |
Organization
Ishikawa Shuzojo Co., Ltd
Division name
Manufacturing division
Zip code
903-0103
Address
Konaha 1438-1, Nishihara-cho, Okinawa
TEL
098-945-3515
Homepage URL
uemac@kamejikomi.com
Sponsor or person
Institute
Ishikawa Shuzojo Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Ishikawa Shuzojo 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
Brain Care Clinic Ethics Review Committee
Address
Isobe Building 2F, Samon-Cho, Shinjyuku-ku, Tokyo
Tel
03-3351-3386
yuyosei@drc-web.co.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
医療法人桜緑会 日本橋さくらクリニック（東京）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | 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
60
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delay Statics Analysis
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
| 2018 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 27 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038665
| Research Plan | |
|---|---|
| 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 |
