UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029526 |
|---|---|
| Receipt number | R000033739 |
| Scientific Title | Effect of constipation by synbiotics intake to dialysis patiens |
| Date of disclosure of the study information | 2017/10/13 |
| Last modified on | 2024/04/19 11:30:11 |
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Basic information
Public title
Effect of constipation by synbiotics intake to dialysis patiens
Acronym
Effect of constipation by synbiotics intake to dialysis patiens
Scientific Title
Effect of constipation by synbiotics intake to dialysis patiens
Scientific Title:Acronym
Effect of constipation by synbiotics intake to dialysis patiens
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dialysis patients are often constipated due to dietary restrictions
and influences of internal medicine, and treated with laxative.
Due to aging, chronic constipation is also a serious issue. A discomfort feeling by constipation cause anorexia, decrease in dietary intake, and subsequent
malnutrition.
We aim to analyze the change of intestinal microbiota and constipation state
for dialysis patients by ingestion of synbiotics food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of fecal microbiota
Key secondary outcomes
Spontaneous bowel movement, Bristol stool form scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Synbiotics group: both water soluble dietary fiber (10g/day) and
Bifidobacterium BB536 (1*10(11)CFU/day) for 4 weeks
Interventions/Control_2
Prebiotics group: water soluble dietary fiber intake 10g/day for 4 weeks
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
Patients during maintaining dialysis who cannot respond to fever or other
infectoin, but can respond to stool and questionnaire.
Key exclusion criteria
Patients other than maintenance dialysis, infection, and dementia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Hori |
Organization
Kobe University Graduate school of Health Sciences
Division name
Department of Biophysics
Zip code
Address
7-10-2,Tomogaoka, Suma-ku, Kobe
TEL
078-792-2555
horiy@people.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Hori |
Organization
Kobe University Graduate school of Health Sciences
Division name
Department of Biophysics
Zip code
Address
7-10-2,Tomogaoka, Suma-ku, Kobe
TEL
078-792-2555
Homepage URL
horiy@people.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate school of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate school of Health Sciences
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
| 2017 | Year | 10 | Month | 13 | 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
| 2017 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033739
