UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effects of synbiotics (Lactobacillus,Bifidobacterium/oligosaccharide) on chronic inflammation in type 2 diabetes mellitus
Acronym	The effects of synbiotics in type 2 diabetes mellitus
Scientific Title	Investigation of the effects of synbiotics (Lactobacillus,Bifidobacterium/oligosaccharide) on chronic inflammation in type 2 diabetes mellitus
Scientific Title:Acronym	The effects of synbiotics in type 2 diabetes mellitus
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether synbiotics administration can improve chronic inflammation in type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of change in IL-6 from 0 to 24 weeks after synbiotics administration between the two groups
Key secondary outcomes	Comparisons of the following parameters between the two groups 1) changes in plasma LBP and C-reactive protein from 0 to 24 weeks 2) total bacterial counts and its detection rate in blood and feces 3) changes in fecal organic acids, fasting blood glucose, liver function, renal function, C-peptide index 4) Analysis of diversity of gut microbiota using next generation sequencer

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are 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	The intervention group takes Supersynbiotics LBG-P(Lactobacillus,Bifidobacterium 3.0g/day and oligosaccharide 20.4g/day) for 24 weeks.
Interventions/Control_2	The control group continues current therapy and takes no synbiotics.
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	1) type 2 diabetes at outpatient clinic at Juntendo University Hospital 2) age 30-79 years old 3) gender male and female 4) patients with diet/exercise therapy only or treated by medicines except alpha-glucosidase inhibitor 5) HbA1c(NGSP) 6.0% and over, but less than 9.0% 6) body mass index 25 and over
Key exclusion criteria	1) liver cirrhosis and renal failure (including hemodialysis and serum creatinine 1.5mg/dL and over) 2) type 1 diabetes 3) inflammatory bowel disease 4) past history of digestive surgery 5) milk allergy 6) not suitable for the study (irregular visit)
Target sample size	88

Research contact person
Name of lead principal investigator	1st name Akio Middle name Last name Kanazawa
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism & Endocrinology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyou-ku, Tokyo
TEL	03-3813-3111
Email	akana@juntendo.ac.jp

Public contact
Name of contact person	1st name Akio Middle name Last name Kanazawa
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism & Endocrinology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyou-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	akana@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Yakult Central Institute
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	human ethics committee of Juntendo University Hospital
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3111
Email	kenkyu5858@juntendo.ac.jp

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 04 Month 02 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	88
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	Completed
Date of protocol fixation	2018 Year 03 Month 23 Day
Date of IRB	2018 Year 03 Month 28 Day
Anticipated trial start date	2018 Year 05 Month 07 Day
Last follow-up date	2020 Year 09 Month 30 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 04 Month 02 Day
Last modified on	2020 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036568