UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044729 |
|---|---|
| Receipt number | R000051069 |
| Scientific Title | Safety evaluation of excessive intake of food containing lactic acid bacteria |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/12/21 15:34:38 |
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Basic information
Public title
Safety evaluation of excessive intake of food containing lactic acid bacteria
Acronym
Safety evaluation of excessive intake of food containing lactic acid bacteria
Scientific Title
Safety evaluation of excessive intake of food containing lactic acid bacteria
Scientific Title:Acronym
Safety evaluation of excessive intake of food containing lactic acid bacteria
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the safety of a daily intake of 300mL of a test food containing lactic acid bacteria for 4 consecutive weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Body weight/body mass index
Doctor's question
Adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 4 consecutive weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 to 64 years old
Key exclusion criteria
(1) Subjects who are judged as unsuitable for the study based on the results of the lifestyle questionnaire
(2) Subjects who have serious disease or history of those illnesses (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine diseases, or metabolic disease)
(3) Subjects who are judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality
(4) Subjects having possibilities for emerging allergy related to the study
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(6) Subjects who have participated in other clinical studies
(7) Subjects who intend to become pregnant or lactating during the test period
(8) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Uchida |
Organization
Yotsuba Milk Products Co., Ltd.
Division name
Research Division R&D Center
Zip code
061-1264
Address
465-1,Wattsu,Kitahiroshima-shi,Hokkaido
TEL
011-377-5561
uchida_k@yotsuba.co.jp
Public contact
Name of contact person
| 1st name | Nahomi |
| Middle name | |
| Last name | Noji |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
noji590@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yotsuba Milk Products Co., Ltd.
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
saito876@eps.co.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
| 2021 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 01 | Day |
Last modified on
| 2021 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051069
