UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032057 |
|---|---|
| Receipt number | 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 17:52:47 |
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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
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
akana@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036568
