UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021888 |
|---|---|
| Receipt number | R000025233 |
| Scientific Title | Effect of continuous intake of fermented milk products on bowel habit in the elderly in a nursing home. How does the result effect facilities administration? |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2016/11/29 10:26:14 |
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Basic information
Public title
Effect of continuous intake of fermented milk products on bowel habit in the elderly in a nursing home. How does the result effect facilities administration?
Acronym
Effect of continuous intake of fermented milk products on bowel habit
Scientific Title
Effect of continuous intake of fermented milk products on bowel habit in the elderly in a nursing home. How does the result effect facilities administration?
Scientific Title:Acronym
Effect of continuous intake of fermented milk products on bowel habit
Region
| Japan |
Condition
Condition
elderly
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirmation of the bowel movement by continuous intake of fermented milk products.we analyze changes of the quantity of expendable supplies to use for excretion.
We inspect cost of adding fermented milk products to meal.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stool frequency ,stool consistency, odor of stool
Key secondary outcomes
Expendable usage
cost of fermented milk products
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Fermented milk products one a day
6months
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly at a nursing home
Key exclusion criteria
Individuals judged by the doctor to be unsuitable.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Ishida |
Organization
Kagawa nutrition university
Division name
Administrative dietetics
Zip code
Address
3-9-21Chiyoda Sakado Saitama
TEL
049-281-3211
ishida@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Ishida |
Organization
Kagawa nutrition university
Division name
Administrative dietetics
Zip code
Address
3-9-21Chiyoda Sakado Saitama
TEL
049-281-3211
Homepage URL
ishida@eiyo.ac.jp
Sponsor or person
Institute
Kagawa nutrition university
Institute
Department
Personal name
Funding Source
Organization
YAKULT HONSHA CO.LTD.Metropolitan Branch
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
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
| 2016 | Year | 04 | Month | 12 | 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
| 2015 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 12 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025233
