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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033918
Receipt No. 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 2019/04/13

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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
Middle name
Last name Uema Choryo
Organization Ishikawa Shuzojo Co., Ltd
Division name Manufacturing division
Zip code
Address Konaha 1438-1, Nishihara-cho, Okinawa
TEL 098-945-3515
Email uemac@kamejikomi.com

Public contact
Name of contact person
1st name
Middle name
Last name Uema Choryo
Organization Ishikawa Shuzojo Co., Ltd
Division name Manufacturing division
Zip code
Address Konaha 1438-1, Nishihara-cho, Okinawa
TEL 098-945-3515
Homepage URL
Email uemac@kamejikomi.com

Sponsor
Institute Ishikawa Shuzojo Co., Ltd
Institute
Department

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
Address
Tel
Email

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
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
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
2019 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038665

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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