UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of probiotics:Lactobacillus casei YIT 9029 (Shirota strain)for the gutmicrobiota of type 2 diabetes
Title of the study (Brief title)	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	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	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	Yuichiro Yamashiro
Organization	Juntendo University
Division name	Department of Probiotics
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	yamasiro@juntendo.ac.jp

Public contact
Name of contact person	Junko Sato
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Metabolism and Endocrinology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5802-1579
Homepage URL
Email	jsato@juntendo.ac.jp

Sponsor
Institute	Department of Probiotics, Juntendo University
Institute
Department

Funding Source
Organization	Yakult Honsha Co., LTD(Yakult Central Institute)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Metabolism and Endocrinology, Juntendo University, Graduate School of Medicine
Name of secondary funｄer(s)	Ministry of Education, Culture, Sports, Science and Technology

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 07 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 08 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021116