UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults
Title of the study (Brief title)	Safety evaluation of excessive intake of functional food containing lactic acid bacteria powder
Region	Japan

Condition
Condition	Healthy adults with or without a tendency for constipation
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to investigate the safety of excessive consumption of food containing lactic acid bacteria powder for 4 weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of side effects during intervention
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	Prevention
Type of intervention	Food
Interventions/Control_1	Intervention Test tablets (containing lactic acid bacteria powder) Duration: 4 weeks Amount: 4.4 g daily
Interventions/Control_2	Control Placebo tablets Duration: 4 weeks Amount: 4.4 g daily
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Japanese untreated males and females from 20 to 69 years of age. (2) Those judged as suitable for the study by the principal investigator. (3) Those who gave the written informed consent before the study.
Key exclusion criteria	(1) A medical history of severe disorders, or continuous medical treatment. (2) A surgical history of digestive system (except appendicectomy) (3) Constantly usage of medical agents for constipation, supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) for intestinal regulation. (4) With allergy to lactic acid bacteria, milk, soybean, or citrus/ (5) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding. (6) Those who drink alcohol a lot or heavy smoker. (7) Those having an extremely irregular diet habit (unexpectedly skipping three or more meals a week) (8) Alternative work schedule, or work on midnight shift. (9) Those who are participating or plan to participate the other clinical tests (foods, medicines, cosmetics or liniments) during the study. (10) Those judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	44

Research contact person
Name of lead principal investigator	Kazuhiko Takano
Organization	Medical Corporation Hokubukai
Division name	Utsukushigaoka Hospital
Address	61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
TEL	011-882-0111
Email	info@csc-smo.co.jp

Public contact
Name of contact person	Isao Takehara
Organization	Clinical Support Corporation
Division name	PI-Food Service Division
Address	4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061, Japan
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	Clinical Support Corporation
Institute
Department

Funding Source
Organization	Asahi Group Holdings, 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 03 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 25 Day
Anticipated trial start date	2016 Year 03 Month 17 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 03 Month 17 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=R000024803