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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032057
Receipt No. R000036568
Scientific Title Investigation of the effects of synbiotics (Lactobacillus,Bifidobacterium/oligosaccharide) on chronic inflammation in type 2 diabetes mellitus
Date of disclosure of the study information 2018/04/02
Last modified on 2020/08/06

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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

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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