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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039159
Receipt No. R000044661
Scientific Title Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Date of disclosure of the study information 2020/01/18
Last modified on 2020/01/15

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Basic information
Public title Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Acronym Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Scientific Title Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Scientific Title:Acronym Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of lactic acid bacterium heat-sterilized at 80 degree centigrade on postprandial blood glucose elevation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postprandial blood glucose levels
Area under the curve(AUC) of postprandial blood glucose levels
Key secondary outcomes Postprandial insulin levels

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 A sucrose tolerance test is conducted at intervals of 3 days or more under physiological saline intake(single ingestion 10mL) and lactic acid bacteria #Ef-1 strain intake(heat-sterilized bacteria at 80 degree centigrade, single ingestion 10mL).
Interventions/Control_2
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1) Subjects who are the age of 20 to less than the age of 60 years old
2) Healthy adult male or female
3) Subjects who are non-diabetic
4) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria 1) Subjects using medical products due to any illness
2) Subjects with a current or past medical history that may affect the test results
3) Subjects who could cause allergic symptoms related to the test products
4) Subjects who regularly use health foods or supplements that may affect glucose metabolism
5) Subjects who have used any drugs within one week prior to the current clinical trial
6) Subjects who have participated in other clinical trials within the last four weeks prior to the current clinical trial
7) Subjects who are judged by the investigator to be inappropriate for participation in this study
Target sample size 2

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Ito
Organization Yotsuya Medical Cube
Division name Gastroenterology
Zip code 102-0084
Address 7-7 Nibancho, Chiyoda-ku,Tokyo
TEL 0332610401
Email ma-itoh@mcube.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Ito
Organization Yotsuya Medical Cube
Division name Gastroenterology
Zip code 102-0084
Address 7-7 Nibancho, Chiyoda-ku,Tokyo
TEL 0332610401
Homepage URL
Email ma-itoh@mcube.jp

Sponsor
Institute Yotsuya Medical Cube
Institute
Department

Funding Source
Organization Genome Pharmaceuticals Institute Co.,Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Yotsuya Medical Cube
Address 7-7 Nibancho, Chiyoda-ku,Tokyo
Tel 0332610401
Email ma-itoh@mcube.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
2020 Year 01 Month 18 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
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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 18 Day
Last follow-up date
2020 Year 01 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 15 Day
Last modified on
2020 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044661

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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