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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016510
Receipt No. 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

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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
Email 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
Email jsato@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019171

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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