UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033020 |
|---|---|
| Receipt number | R000036165 |
| Scientific Title | Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2023/06/19 10:45:05 |
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Basic information
Public title
Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients
Acronym
Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients
Scientific Title
Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients
Scientific Title:Acronym
Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We Investigate the impact on the intestinal bacteria by initiation of dialysis in patients with chronic kidney disease, and also by synbiotics intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The variation in blood concentrations of p-cresol is measured before initiation of dialysis and four weeks after initiation. Participants are randomized to symbiotic intake or no treatment. After four weeks intervention, the changes in blood P cresol values are compared.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1 packet of Yakult Super Synbiotics as probiotics and 6.8g of Oligosaccharide as prebiotics three times a day for four weeks.
Yakult Super Synbiotics contains Lactobacillus casei strain Shirt and Bifidobacterium breve strain Yakult.
Interventions/Control_2
no treatment
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
1)Patients with CKD stage 5 (eGFR <15 mL/min/1.73 m2)
2)Patients scheduled to undergo dialysis within about 3 months
3)More than 20 years old, either sex
4) Patients who are able to provide informed consent
Key exclusion criteria
1) Patients who received antibacterial treatment by oral or intravenous administration within 1 week before the introduction of dialysis
2) Patients who ingested the study drug of this study or similar substances within 1 week before the introduction of dialysis
3) Patients who received or ingested lactic acid bacteria-containing preparations or oligosaccharide preparations manufactured by Yakult Co., Ltd. within 2 weeks before the introduction of dialysis.
4) Patients who used an intestinal regulator or an oral medical spherical adsorption charcoal within 2 weeks before the introduction of dialysis
5) Patients taking immunosuppressive agents within 6 months before the introduction of dialysis
6) Patients with acute renal failure
7) Patients who have had a kidney transplant before
8) Patients with irritable bowel syndrome, Crohn's disease, ulcerative colitis
9) Patients who have been allergic to milk
10) Pregnant or potentially pregnant women
11) Breastfeeding women
12) Patients who received another study drug or study drug within 3 months before the start of administration of the study drug
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Sumi |
| Middle name | |
| Last name | Hidaka |
Organization
ShonanKamakura General Hospital
Division name
Kidney Disease and Transplant Center
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura, Kanagawa
TEL
0467-46-1717
s_hidaka@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hirata |
Organization
ShonanKamakura General Hospital
Division name
Clinical Research Division, Support Office
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura, Kanagawa
TEL
0467-46-1717
Homepage URL
m_hirata@shonankamakura.or.jp
Sponsor or person
Institute
ShonanKamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
ShonanKamakura General Hospital
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
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2018 | Year | 07 | Month | 01 | 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
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2018 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036165
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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