UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014814 |
|---|---|
| Receipt number | R000017223 |
| Scientific Title | The analysis of influences on the gut microbiota, the glycometabolism and the peritoneal permeability by the induction of dialysis and the peritonitis prevalence in peritoneal dialysis patients. |
| Date of disclosure of the study information | 2014/08/10 |
| Last modified on | 2019/09/25 09:27:54 |
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Basic information
Public title
The analysis of influences on the gut microbiota, the glycometabolism and the peritoneal permeability by the induction of dialysis and the peritonitis prevalence in peritoneal dialysis patients.
Acronym
The analysis of gut microbiota in dialysis patients.
Scientific Title
The analysis of influences on the gut microbiota, the glycometabolism and the peritoneal permeability by the induction of dialysis and the peritonitis prevalence in peritoneal dialysis patients.
Scientific Title:Acronym
The analysis of gut microbiota in dialysis patients.
Region
| Japan |
Condition
Condition
end stage renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analysis the influences on gut microbiota and glycometabolism by the induction of dialysis.
Basic objectives2
Others
Basic objectives -Others
To analysis the influences on gut microbiota, glycometabolism and peritoneal permeability by the induction of automated peritoneal dialysis and the peritonitis prevalence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of gut microbiota and the analysis of the fluctuation of blood glucose by continuous glucose monitoring system.
Key secondary outcomes
The change of peritoneal permeability by the induction of automated peritoneal dialysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)chronic kidney disease stage 5
2)peritoneal dialysis patients
Key exclusion criteria
1)the morbidity of the dementia and psychological disease
2)renal transplantation
3)hybrid therapy by hemodialysis and peritoneal dialysis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Itoh |
Organization
Keio university school of medicine
Division name
Nephrology, Endocrinology and Metabolism
Zip code
Address
Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL
+81-3-5363-3878
hiito@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Washida |
Organization
Keio university school of medicine
Division name
Integrated renal replacement therapy translational medicine
Zip code
Address
Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL
+81-3-3353-1211
Homepage URL
naoki_washida@yahoo.co.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Keio university school of medicine
Organization
Division
Category of Funding Organization
Other
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 | 08 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
glycometabolism, gut microbiota, peritoneal permeability
Management information
Registered date
| 2014 | Year | 08 | Month | 10 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017223
