UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016510 |
|---|---|
| Receipt number | R000019171 |
| Scientific Title | The effect of probiotics:Lactobacillus casei YIT 9029 (Shirota strain)for the gutmicrobiota of type 2 diabetes |
| Date of disclosure of the study information | 2015/02/12 |
| Last modified on | 2015/07/08 14:32:46 |
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Basic information
Public title
The effect of probiotics:Lactobacillus casei YIT 9029 (Shirota strain)for the gutmicrobiota of type 2 diabetes
Acronym
The effect of probiotics:Lactobacillus casei YIT 9029 (Shirota strain)for the gutmicrobiota of type 2 diabetes
Scientific Title
The effect of probiotics:Lactobacillus casei YIT 9029 (Shirota strain)for the gutmicrobiota of type 2 diabetes
Scientific Title:Acronym
The effect of probiotics:Lactobacillus casei YIT 9029 (Shirota strain)for the gutmicrobiota of type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and efficacy of probiotics, Shirota strain for the patients of type 2 diabetes,with the change of gutmicrobiota,the detection rate of gutmicrobiota in the blood,inflammatory cytokines and diabetes control etc.before and after the study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)The change of gutmicrobiota before and after the study
2)The change of the detection rate of gutmicrobiota in the blood before and after the study
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
With Lactobacillus casei YIT 9029
Interventions/Control_2
Without Lactobacillus casei YIT 9029
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
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients with HbA1c 6.0%-7.9 %
Key exclusion criteria
1)With liver and renal dysfunction
2)With type 1 diabetes
3)With inflammatory bowel disease
4)After the operation of gastrointestinal disease
5)BMI >=20,<=35
6)Taking alpha glucosidase inhibitor
7)Inappropriate for the study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yamashiro |
Organization
Juntendo University
Division name
Department of Probiotics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
yamasiro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Sato |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1579
Homepage URL
jsato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yakult Honsha Co., LTD(Yakult Central Institute)
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
| 2015 | Year | 02 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 20 | 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
| 2015 | Year | 02 | Month | 11 | Day |
Last modified on
| 2015 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019171
| 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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