UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. An open trial.
Title of the study (Brief title)	A study for evaluating the viability of lactic acid bacteria in intestinal tract after intake of food containing lactic acid bacteria.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether viable Lactobacillus brevis is detected in the feces after ingestion of food containing lactic acid bacteria for healthy volunteers.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number and rate of subjects that viable Lactobacillus brevis is detected in their feces after ingestion of test food. Number of viable Lactobacillus brevis in the feces
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	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing lactic acid bacteria
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) Males and females from 20 to 64 years of age (2) Subjects who have a daily bowel movement (3) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals with a loose stool and/or a tendency for constipation (2) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or health foods in common use, including food for specified health use (3) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use (4) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period (5) Individuals presenting known food allergy (6) Individuals taking large amounts of alcohol on a daily basis (7) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications (8) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (9) Individuals who are under treatment or have a history of irritable bowel syndrome (10) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire (11) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (12) Individuals who are under treatment or have a history of drug/alcohol dependence (13) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (14) Subjects with defecation more than 14 times per week (15) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	Satoru Suzuki
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Medical examination and treatment management family chief director
Address	1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL	03-3452-3381
Email	satoru_suzuki@sempos.or.jp

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

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Lotte 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	2017 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 26 Day
Anticipated trial start date	2017 Year 01 Month 21 Day
Last follow-up date	2017 Year 02 Month 18 Day
Date of closure to data entry	2017 Year 03 Month 13 Day
Date trial data considered complete	2017 Year 03 Month 15 Day
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 01 Month 17 Day
Last modified on	2017 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029557