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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039471
Receipt No. R000045005
Scientific Title A confirmation test of Intestine regulating effects by ingesting test foods
Date of disclosure of the study information 2021/02/17
Last modified on 2021/02/10

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Basic information
Public title A confirmation test of Intestine regulating effects by ingesting test foods
Acronym A confirmation test of Intestine regulating effects by ingesting test foods
Scientific Title A confirmation test of Intestine regulating effects by ingesting test foods
Scientific Title:Acronym A confirmation test of Intestine regulating effects by ingesting test foods
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is a confirmation of bowel control effects for subjects who tend loose stool by ingesting test foods.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes * Defecation situation (number of defecation, days of defecation, Bristol Stool Scale score)
* Intestinal microbiota (T-RFLP method)
Key secondary outcomes * Defecation situations (odor of stool, color of stool, exhilaration of defecation, abdominal symptoms)
* GSRS questionnaire
* Fecal organic acids
* Fecal ammonia
* Fecal decay products
* Fecal properties (pH, water contents)

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 Prevention
Type of intervention
Food
Interventions/Control_1 Ingesting one capsule of test food a day for four weeks.
Interventions/Control_2 Ingesting one capsule of control food a day for four weeks.
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Males and females of Japanese aged 20 to 65 years old.
(2) Subjects who have troubles because of loose stool.
(3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria (1) Subjects who are given continuous treatment by taking medicines.
(2) Subjects who use medicines, food for specified health use, functional foods, health foods and supplements more than 3 days a week, those possibly have improving effect of defecation and/or loose stool.
(3) Subjects who eat food products containing relatively large amount of yogurt, lactic bacteria beverages and dietary fiber more than 3 days a week.
(4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ) containing history of surgical operations.
(6) Subjects who excessive alcohol intake.
(7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(8) Subjects who have previous medical history of drug and/or food allergy (especially to milk and/or to shellfish).
(9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(11) Subjects who donated over 400mL blood and/or blood components within the last three months to the current study.
(12) Females who donated over 400mL blood and/or blood components within the last four months to the current study.
(13) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(14) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
(15) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 56

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Ikemoto
Organization NISSHIN PHARMA INC.
Division name HEALTH CARE RESEARCH CENTER
Zip code 356-8511
Address 5-3-1, Tsurugaoka, Fujimino-city, Saitama, 356-8511, Japan
TEL 049-267-3940
Email ikemoto.hiroyuki@nisshin.com

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Numa
Organization CPCC Company Limited
Division name Planning & Sales Department
Zip code 101-0047
Address 4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization NISSHIN PHARMA INC.
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 Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel 03-5297-5548
Email IRB@cpcc.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

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 17 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 01 Month 20 Day
Date of IRB
2020 Year 01 Month 17 Day
Anticipated trial start date
2020 Year 02 Month 17 Day
Last follow-up date
2020 Year 04 Month 23 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 02 Month 13 Day
Last modified on
2021 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045005

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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