UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022416 |
|---|---|
| Receipt number | R000025832 |
| 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 | 2016/05/23 |
| Last modified on | 2016/11/29 10:22:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
inpatient, nursing staff
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are as follows: (1) to evaluate changes in defecation among patients admitted to a psychiatric hospital when fermented milk products are ingested on a regular basis; (2) to evaluate the changes in expenditure owing to (i) the amount of purgatives used for treating disorders related to defecation and (ii) the purchase of fermented milk products required to be added to the normal diet; and (3) to verify whether the sense of burden among the nursing staff who assist patients with defecation is changed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the amount of purgatives
stool frequency ,stool consistency, odor of stool,
Change of caregiver burden on nursing staff
One week before intervention start,
3 months later, 6 months later,
intervention end one month later
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 6 months
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
A mental hospital inpatient and nursing staff
Key exclusion criteria
Individuals judged by the doctor to be unsuitable.
Target sample size
100
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 | 05 | Month | 23 | 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
| 2016 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 09 | 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
| 2016 | Year | 05 | Month | 23 | 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=R000025832
