UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024112 |
|---|---|
| Receipt number | R000027756 |
| Scientific Title | Improvement effect of substance X on human bowel movement. |
| Date of disclosure of the study information | 2016/09/20 |
| Last modified on | 2020/01/31 16:12:48 |
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Basic information
Public title
Improvement effect of substance X on human bowel movement.
Acronym
Improvement effect of substance X on human bowel movement.
Scientific Title
Improvement effect of substance X on human bowel movement.
Scientific Title:Acronym
Improvement effect of substance X on human bowel movement.
Region
| Japan |
Condition
Condition
Tendency for constipation
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement effect of beverages containing substance X on human constipation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation days, defecation frequency
Key secondary outcomes
1)Amount of feces, fecal condition (form, color, smell, feeling after defecation)
2)Change of subjective symptoms of intolerance to cold
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test beverage A (contaning low-dose X) for 2-week intake -> 2-week washout -> Placebo beverage (control) for 2-week intake
Interventions/Control_2
Placebo beverage (control) for 2-week intake -> 2-week washout -> Test beverage A for 2-week intake
Interventions/Control_3
Test beverage B (contaning high-dose X) for 2-week intake -> 2-week washout -> Placebo beverage (control) for 2-week intake
Interventions/Control_4
Placebo beverage (control) for 2-week intake -> 2-week washout -> Test beverage B for 2-week intake
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese Subjects.
2)Subjects with tendency for constipation (at 4 times or less of defecation per week).
3)Subjects who take regular meals.
Key exclusion criteria
1)Subjects with medical history of severe disorders.
2)Subjects with continuous medical treatment.
3)Subjects with surgical history of digestive system (except appendectomy).
4)Subjects who take any kind of medicine (intestinal, laxative medicine etc) regularly that possibly affect bowel movement.
5) Subjects who take supplements and/or functional foods (including Food for Specified Health Uses [FOSHU] regularly that possibly affect bowel movement.
6)Pregnant or have possibility to become pregnant during the study or lactating women.
7)Subjects who drink alcohol a lot regularly.
8)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ishida |
Organization
Hayashibara CO., LTD.
Division name
R & D Division, Development Unit
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
086-276-3141
yuki.ishida@hb.nagase.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ishida |
Organization
Hayashibara CO., LTD.
Division name
R & D Division, Development Unit
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
086-276-3141
Homepage URL
yuki.ishida@hb.nagase.co.jp
Sponsor or person
Institute
Medical Corporation Hokubukai, Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Clinical Support Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Medical Corporation Hokubu-kai Utsukushigaoka Hospital
Address
61-1, Shinei, Kiyota-ku, Sapporo
Tel
011-882-0111
wakimoto@ughp-cpc.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
医療法人北武会 美しが丘病院 (北海道) / Medical Corporation Hokubukai, Utsukushigaoka Hospital (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 20 | 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
40
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
| 2016 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 01 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027756
