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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014814
Receipt No. 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 2017/08/12

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Last 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
Email hiito@z8.keio.jp

Public contact
1st 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
Email naoki_washida@yahoo.co.jp

Sponsor
Institute Keio university school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 11 Day
Last follow-up date
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
2017 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017223


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