UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effects of drink-A containing lactic acid bacteria
Title of the study (Brief title)	Evaluation of the effects of drink-A 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	Confirm the effectiveness of the beverage containing Lactobacillus casei NY1301 strain on constipated adults'intestine for 2weeks.
Basic objectives2	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,Intestinal flora(Real-Time PCR),Fecal ammonia content,Fecal pH,Fecal moisture content

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	Intake of drink containing lactic acid bacteria for 2 weeks
Interventions/Control_2	Intake of placebo drink for 2 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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1)Subjects from 20 to 69 years-old 2)Subjects with constipation tendency (their defecation frequency is 2 to 4 times a week in the past about 3 months,and constipation is not so severe) 3)Subjects undergoing none of medical treatments 4)Subjects who can record daily logs during the designated period 5)Subjects who can record diet records on specified days 6)Subjects who can visit during the designated period 7)Subjects who can collect and submit a sample during the designated period
Key exclusion criteria	1)Subjects with serious liver disease,renal/heart disease,organ disorder,diabetes,food allergy,gastrointestinal disease,other serious diseases 2)Subjects have a medical history or a surgical history of digestive diseases 3)Subjects allergic to a specific drug or food 4)Subjects allergic to samples in this study 5)Subjects with a large influence on defecation during menstruation or in poor physical condition 6)Pregnants,lactating women or who is going to be pregnant during study 7)Subjects drawn blood over 200mL last 1 month,or over 400mL last3 months before consent acquisition date 8)Subjects scheduled for medical examination during study 9)Subjects who can't maintain everyday life habits 10)Subjects who do not ingest three meals a day 11)Subjects who do not ingest beverages at breakfast 12)Subjects working at night or in rotation 13)Subjects with a several variation of the amount of diet or movement 14)Subjects drink alcohol over 500mL in terms of beer per day 15)Subjects smoke over average 20 cigarettes per day 16)Subjects who have any kinds of drugs affect this study (constipation drugs,intestinal drugs,antibiotics,etc.) 17)Subjects who can not refrain from using health foods,during the study 18)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 19)Subjects who can not take the test food as instructed 20)Subjects who have participated in the other clinical studies 21)Subjects 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 Fujisawa
Organization	Ageo Central Second Hospital
Division name	Director
Address	421-1 , Jitougata, Ageo-shi, Saitama
TEL	048-781-1101
Email	susumu.hosonuma@achs.jp

Public contact
Name of contact person	Soichi Yoneda
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Food Test Division
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo,Japan
TEL	03-6386-8809
Homepage URL
Email	s-yoneda@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION 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	上尾中央第二病院（埼玉県）、白岡中央総合病院（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）、笛吹中央病院（山梨県）、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）、金内メディカルクリニック（東京都）、クロス病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 25 Day
Anticipated trial start date	2018 Year 04 Month 03 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	2018 Year 02 Month 22 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035852