UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012889 |
|---|---|
| Receipt number | R000015051 |
| Scientific Title | Efficacy of probiotic food containing bifidobacterium for chronic constipation in maintenace hemodialysis patients. |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2014/07/18 09:54:53 |
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Basic information
Public title
Efficacy of probiotic food containing bifidobacterium for chronic constipation in maintenace hemodialysis patients.
Acronym
Evaluation for clinical efficacy of bifidobacterium
Scientific Title
Efficacy of probiotic food containing bifidobacterium for chronic constipation in maintenace hemodialysis patients.
Scientific Title:Acronym
Evaluation for clinical efficacy of bifidobacterium
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of therapeutic efficacy of probiotic food containing bifidobacterium
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of improvement of chronic constipation in hemodialysis patients by comparing the "constipation score" between before and after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administration of probiotic for selected patients for the study period of three 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who are able to understand the meaning of this research and are able to follow our instructions.
Key exclusion criteria
Adult patients who are dementia or have difficulty to follow our instructions.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Ishikawa |
Organization
Tokai Central Hospiotal of Japan Mutual Aid Association of Public School Teachers
Division name
Department of Nephrology
Zip code
Address
Sohara-Higashishima-4-6-2 Kagamigahara Gifu Japan
TEL
058-382-3101
hide1973@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Ishikawa |
Organization
Tokai Central Hospiotal of Japan Mutual Aid Association of Public School Teachers
Division name
Nephrology
Zip code
Address
Sohara-Higashishima-4-6-2 Kagamigahara Gifu Japan
TEL
058-382-3101
Homepage URL
hide1973@med.nagoya-u.ac.jp
Sponsor or person
Institute
Tokai Central Hospiotal of Japan Mutual Aid Association of Public School Teachers
Institute
Department
Personal name
Funding Source
Organization
Tokai Central Hospiotal of Japan Mutual Aid Association of Public School Teachers
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://tokaihp-jinzou-naika.jimdo.com/
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
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 17 | Day |
Last modified on
| 2014 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015051
