UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The beneficial effect of a newly developed functional food (beverage) containing Lactobacillus powder on human gastrointestinal function.
Title of the study (Brief title)	The beneficial effect of a beverage containing Lactobacillus powder on human gastrointestinal function.
Region	Japan

Condition
Condition	Individuals with a tendency for constipation or loose stool
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to investigate the efficacy and safety of the intake of the test beverages for 3 weeks on persons with constipation or frequent loose stool.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency, defecation days, fecal condition
Key secondary outcomes	Intestinal microflora composition, organic acids, putrefactive products, questionnaire for QOL

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 beverage (containing Lactobacillus powder) Duration: 3 weeks Amount: 200 mL/ bottle, 1 bottle daily
Interventions/Control_2	Control Placebo beverage Duration: 3 weeks Amount: 200 mL/ bottle, 1 bottle 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 males and females from 20 to 70 years of age. (2) Those with a tendency for constipation (at 4 times or less of defecation per week), and for loose stool (at 10 times or more of defecation per week). (3) Those taking regular meals.
Key exclusion criteria	(1) A medical history of severe disorders, or continuous medical treatment. (2) A surgical history of digestive system (except appendicectomy) (3) Watery stool daily (4) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding. (5) Constantly usage of supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) affecting the test results. (6) Those having an extremely irregular diet habit, alternative work schedule, or work on midnight shift. (7) Those who drink alcohol a lot. (8) Withdrawal of whole blood more than 400mL within 12 weeks, or more than 200mL within 4 weeks, or withdrawal of blood components prior to the current study. (9) Those judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	120

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	001-882-0111
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	Calpis Co. Ltd.
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	2015 Year 03 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 12 Day
Anticipated trial start date	2015 Year 03 Month 12 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	Published
URL releasing results	http://www.microbecolhealthdis.net/index.php/mehd/article/view/30259
Results
Other related information

Management information
Registered date	2015 Year 03 Month 11 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=R000019466