UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036151 |
|---|---|
| Receipt number | R000041192 |
| Scientific Title | Safety evaluation of excessive intake of drink containing lactic acid bacteria for healthy adults. |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2019/07/30 09:06:02 |
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Basic information
Public title
Safety evaluation of excessive intake of drink containing lactic acid bacteria for healthy adults.
Acronym
Safety evaluation of excessive intake of drink containing lactic acid bacteria for healthy adults.
Scientific Title
Safety evaluation of excessive intake of drink containing lactic acid bacteria for healthy adults.
Scientific Title:Acronym
Safety evaluation of excessive intake of drink containing lactic acid bacteria for healthy adults.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the safety of excessive intake of drink containing lactic acid bacteria, 3-fold quantity of recommended daily amount of intake for 4 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Biochemical test
Urine analysis
Blood pressure/Pulse rate
Weight/body mass index
Doctor's questions
Adverse event
Evaluate at points of 2 and 4 weeks of ingestion and 2 weeks after the end of ingestion period
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 product,3-fold quantity for 4 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
(1)Healthy males and females from 20 to 64 years of age
(2)Subjects falling under any of the following answer of the lifestyle questionnaire in the preliminary examination
A.Subjects with a tendency for constipation at three to five times of defecation per week
B.Subjects with a tendency for constipation at seven times of defecation per week
Key exclusion criteria
(1)Subjects judged as unstable for this study based on the results of clinical examination or cardiopulmonary abnormality
(2)Subjects have possibilities to develop an allergy to the test product
(3)Subjects have a disease requiring regular medication or a history of serious diseases for which medication was required.
(4)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(5)Subjects who have participated in other clinical studies
(6)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(7)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(8)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Saito |
Organization
Medical Station Clinic
Division name
None
Zip code
152-0004
Address
3-12-8 Takaban, Meguro-ku, Tokyo, Japan
TEL
03-6452-2712
info@med-station.jp
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Furuhata |
Organization
TTC Co., Ltd
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo, Japan
TEL
03-5459-5329
Homepage URL
t.furuhata@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Nissin York 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
Aisei Hospital Ueno Clinic Reserch Ethics Committee
Address
2-18-6 Higashiueno, Taito-ku, Tokyo, Japan
Tel
03-6455-0880
t.saito@ttc-smo.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
| 2019 | Year | 03 | Month | 11 | 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
| 2019 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 06 | 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
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041192
