UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049382 |
|---|---|
| Receipt number | R000056232 |
| Scientific Title | Clinical trial of additional effects of lactic acid bacteria metabolites A6 for diabetes patients |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2022/10/31 23:05:48 |
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Basic information
Public title
Clinical trial of additional effects of lactic acid bacteria metabolites A6 for diabetes patients
Acronym
Clinical trial of additional effects of lactic acid bacteria metabolites for diabetes patients
Scientific Title
Clinical trial of additional effects of lactic acid bacteria metabolites A6 for diabetes patients
Scientific Title:Acronym
Clinical trial of additional effects of lactic acid bacteria metabolites for diabetes patients
Region
| Asia(except Japan) |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of ingestion of the lactic acid bacteria metabolites in Chinese diabetic patients undergoing treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical index
Patient's subjective symptoms and doctor's findings
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
giving low doses of lactic acid bacteria metabolites
Interventions/Control_2
giving high doses of lactic acid bacteria metabolites
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
| 31 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diabetes patients whose diagnostic standard is a fasting blood glucose level of 120 mg/dl or higher, or a fasting blood glucose level of 180 mg/dl or higher 2 hours after a meal, according to WHO criteria
Key exclusion criteria
1. Those with infectious diseases
2. Patients undergoing dialysis treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kaneko |
Organization
KOEI SCIENCE LABORATORY Co., Ltd.
Division name
Sales Department
Zip code
351-0115
Address
5-1-25 Niikura, Wako City, Saitama Prefecture
TEL
048-467-3345
kaneko@koei-science.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kaneko |
Organization
KOEI SCIENCE LABORATORY Co., Ltd.
Division name
Sales Department
Zip code
351-0115
Address
5-1-25 Niikura, Wako City, Saitama Prefecture
TEL
048-467-3345
Homepage URL
kaneko@koei-science.com
Sponsor or person
Institute
KOEI SCIENCE LABORATORY Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
China-Japan Friendship Hospital, Beijing
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KOEI SCIENCE LABORATORY Co., Ltd.
Address
5-1-25 Niikura, Wako City, Saitama Prefecture 351-0115
Tel
048-467-3345
kaneko@koei-science.com
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
| 2022 | Year | 10 | Month | 31 | 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
100
Results
The rate of effect was significantly higher in the high dose group compared to the low dose group. In both groups, fasting blood glucose and HbA1c levels were significantly reduced after the test compared to before the test.
Results date posted
| 2022 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
diabetes patients
Participant flow
According to the WHO criteria, a fasting blood sugar level of 120 mg/dl or higher, or a fasting blood sugar level of 180 mg/dl or higher 2 hours after a meal was used as the diagnostic standard for diabetes.
Adverse events
none
Outcome measures
Biochemical index
Patient's subjective symptoms and doctor's findings
Plan to share IPD
Under consideration
IPD sharing Plan description
Under consideration
Progress
Recruitment status
Completed
Date of protocol fixation
| 1998 | Year | 05 | Month | 01 | Day |
Date of IRB
| 1998 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 1999 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 31 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056232
