UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the safety of excessive intake of fermented milk drink. -Open study-
Title of the study (Brief title)	A clinical study for evaluating the safety of excessive intake of fermented milk drink.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of excessive intake of fermented milk drink for 4 weeks in healthy adults.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Biochemistry test Urinalysis Blood pressure/pulse Weight/body mass index Medical interview 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	Treatment
Type of intervention	Food
Interventions/Control_1	Consumption of fermented milk drink, 3-fold quantity of recommended daily intake, 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy men and women aged 20 to 64 years old. 2) Subjects who tend to be constipated (defecation frequency is 3-5 times per week) or have daily defecation. 3) Subjects who eat 3 meals regularly in one day. 4) Subjects who can stop drinking from 2 days before each inspection date. 5) Subjects who understand details of the study and provides informed consent by documents.
Key exclusion criteria	1) Subjects who regularly use intestinal drugs or laxatives. 2) Subjects who have severe complication or serious diseases requiring an urgent treatment. 3) Subjects who have a chronic disease and use medicines constantly. 4) Subjects who have medical history of diseases or surgeries which affect digestion and absorption. 5) Subjects who repeat constipation and diarrhea such as irritable colitis. 6) Subjects who regularly use functional foods which help relieve constipation (including Food for Specified Health Uses, Foods with Function Claims) 7) Subjects who take drugs which affect digestion and absorption such as antibiotics at screening test. 8) Subjects who can't stop ingesting food containing lactic acid bacteria, bifidobacteria, oligosaccharide and viable bacteria, large amounts of sugar alcohol or functional foods (including Food for Specified Health Uses, Foods with Function Claims) which help relieve constipation. 9) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 10) Subjects who have tendency to get diarrhea by ingesting milk. 11) Subjects who have food allergy. 12) Subjects who are judged as unsuitable for the study by screening questionnaire. 13) Subjects who are judged as unsuitable for the study by the blood test results of screening test. 14) Subjects who are planning to become pregnant during the study or are pregnant or lactating. 15) Subjects who are planning to participate or already participating in other clinical studies. 16) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	Yasuo Kobuna
Organization	Kobuna Orthopedics Clinic
Division name	Director
Address	311-2 Gokan-machi, Maebashi-shi, Gumma, Japan
TEL	027-261-7600
Email	info@kobunaseikei.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Yakult Honsha 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	2016 Year 10 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 07 Day
Anticipated trial start date	2016 Year 10 Month 11 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
Other related information

Management information
Registered date	2016 Year 10 Month 10 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028033