UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050555 |
|---|---|
| Receipt number | R000057407 |
| Scientific Title | Verification of the effects of intaking "11/19-B1 Yogurt" on serum uremic toxins, LDL levels, immune function and improvement of defecation in dialysis patients - Single group study - |
| Date of disclosure of the study information | 2023/03/11 |
| Last modified on | 2023/03/10 12:26:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of intake of 11/19-B1 Yogurt on dialysis patients.
Acronym
The effect test of intaking "11/19-B1 Yogurt"
Scientific Title
Verification of the effects of intaking "11/19-B1 Yogurt" on serum uremic toxins, LDL levels, immune function and improvement of defecation in dialysis patients - Single group study -
Scientific Title:Acronym
Verification of the effect of intaking "11/19-B1 Yogurt" on dialysis patients.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of "11/19-B1 yogurt" intake on serum uremic toxins, LDL levels, immune function, and improvement of defecation in dialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood indoxyl sulfate concentration
Blood trimethylamine N oxide
Serum LDL level
Cellular immunity
Defecation evaluation
(These tests are evaluated 4 weeks before intake, before intake, 4 weeks and 8 weeks after intake, and 4 weeks and 8 weeks after the end of intake.)
Key secondary outcomes
Stool test (fecal intestinal flora)
regular inspection
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
To intake "11/19-B1 Yogurt" (50g/day) for 8 weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are undergoing dialysis treatment and have no milk allergy
Patients who consented to participate in this study
Key exclusion criteria
Subjects with milk allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Suzutani |
Organization
Fukushima Medical University
Division name
Department of Microbiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024(547)1158
suzutani@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Suzutani |
Organization
Fukushima Medical University
Division name
Department of Microbiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima 960-1295, Japan
TEL
0245471158
Homepage URL
suzutani@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Rakuo Kyodo Dairy Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Mito Hospital, Nephrology
Rakuo Kyodo Dairy Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University, Research Ethics Committee
Address
1 Hikarigaoka, Fukushima 960-1295, Japan
Tel
0245472111
fmurec@fmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
REC2022-011
Org. issuing International ID_1
Fukushima Medical University, Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057407
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
