UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-finding study of drink-B containing lactic acid bacteria
Title of the study (Brief title)	Dose-finding study of drink-B containing lactic acid bacteria
Region	Japan

Condition
Condition	Subjects who have a tendency to be constipated
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Calculation of effective dose of the drink containing Lactobacillus casei NY1301 on bowel movement of subjects who have a tendency to be constipated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency, fecal amount
Key secondary outcomes	Fecal shape, fecal color, feelings after defecation, analysis of intestinal microflora

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of drink containing high-dose lactic acid bacteria for 2 weeks
Interventions/Control_2	Intake of drink containing low-dose lactic acid bacteria for 2 weeks
Interventions/Control_3	Intake of placebo drink for 2 weeks
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)Males and females from 20 to 70 years-old (2)Subjects who have a tendency to be constipated defecate two to five times a week (3)Subjects undergoing none of medical treatments (4)Subjects eat regularly
Key exclusion criteria	(1)Subjects with a serious disease (2)Subjects have a medical history or a surgical history of digestive diseases (3)Subjects allergic to a specific drug or food (4)Subjects work alternative or midnight shifts (5)Subjects never be able to stop intaking foods or drinks which improve constipation during study,such as foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers and/or other health foods including food for specified health use (6)Subjects who have any kinds of drugs affect this study (constipation drugs, intestinal drugs, etc.) (7)Subjects drink alcohol over 500mL in terms of beer per day (8)Subjects smoke over 20 cigarettes per day (9)Subjects drawn blood over 200mL last 1 month, or over 400mL last 3 months (10)Subjects allergic to samples in this study (11)Pregnants, lactating women or who is going to be pregnant (12)Subjects who have participated in the other clinical studies (13)Subjects judged as unsuitable for the study by the principal investigator for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroshi Moriyama
Organization	Kanazawabunko Hospital
Division name	Vice president
Address	2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama city,Kanagawa,Japan
TEL	045-785-3311
Email	nagashima@kanabun-hp.jp

Public contact
Name of contact person	Soichi Yoneda
Organization	QOL RD Co.,Ltd.
Division name	CRO Department Food Division
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo,Japan
TEL	03-6386-8809
Homepage URL
Email	s-yoneda@qol-rd.co.jp

Sponsor
Institute	QOL RD 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)

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	金沢文庫病院（神奈川県）、上尾甦生病院（埼玉県）、白岡中央総合病院（埼玉県）、さがみリハビリテーション病院（神奈川県）、メディカルトピア草加病院（埼玉県）、桜ヶ丘中央病院（神奈川県）、横浜なみきリハビリテーション病院（神奈川県）、浅草病院（東京都）、武蔵境クリニック（東京都）、日本橋ハートクリニック（東京都）、八木病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 20 Day
Anticipated trial start date	2017 Year 03 Month 29 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	2017 Year 03 Month 17 Day
Last modified on	2017 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030535