UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for safety evaluation of long-term consumption of the test food.
Title of the study (Brief title)	A study for safety evaluation of long-term consumption of the test food.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety evaluation when healthy adults consume the one piece of test food per day (100 g) for 12 weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data). (2) Presence or absence of abnormal variations in clinical test data.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	Intake of test drink containing B. lactis GCL2505(concentration of 1X10^10CFU)and inulin (2g) for 12 weeks.
Interventions/Control_2	Intake of placebo drink (not containing B. lactis GCL2505 and inulin) for 12 weeks.
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Male and female aged over 20 to 59 years old when acquisition consent. (2) Subjects who take regular meals three times a day. (3) Subjects who can abstain from alcohol 2 days before each test. (4) Subjects who do not repeat constipation and diarrhea on a daily basis. (5) Subjects who do not have serious complications. (6) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	(1) Subjects who have lactose intolerance. (2) Subjects who can't refrain restricted and/or prohibited foods during the test. (3) Subjects who take medications that affect intestinal environment, digestion and absorption at the time of advance inspection. (4) Subjects who regularly use laxatives, intestinal regulator, etc. (5) Pregnant or possibly pregnant, or lactating women. (6) Subjects who have a history of and/or current medical history of severe diseases such as heart, liver, kidney, digestive organs, drug dependence, alcohol dependence. (7) Subjects who excessive alcohol intake. (8) Subjects who have extremely irregular life rhythms, and have midnight work or irregular shift work. (9) Subjects who have previous medical history of drug and/or food allergy. (10) Subjects who have chronic illness and regularly use medicines. (11) Subjects who were judged unsuitable for the clinical test from the results of the blood test at advance inspection. (12) Subjects who are participating the other clinical tests and participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (13) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (14) Males who donated over 400mL blood and/or blood components within the last three months to the current study. (15) Females who donated over 400mL blood and/or blood components within the last four months to the current study. (16) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (17) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (18) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Suguru Fujiwara
Organization	CPCC Co., Ltd.
Division name	Clinical Research Planning Department
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Co., Ltd.
Division name	Sales & Planning division
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Co., Ltd.
Institute
Department

Funding Source
Organization	Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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 08 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 15 Day
Anticipated trial start date	2018 Year 04 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	It was judged that there was no problem in safety.
Other related information

Management information
Registered date	2018 Year 04 Month 20 Day
Last modified on	2019 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036837