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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029526
Receipt No. 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 2017/10/12

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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
Email 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
Email horiy@people.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate school of Health Sciences
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 04 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
2017 Year 10 Month 12 Day
Last modified on
2017 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033739

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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