UMIN-CTR Clinical Trial

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