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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036151
Receipt No. 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

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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
Email 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
Email t.furuhata@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041192

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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