UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039471 |
|---|---|
| Receipt number | 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 09:19:26 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045005
