UMIN-CTR Clinical Trial

Basic information
Public title	A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. Second report, an open trial.
Acronym	A study for evaluating the viability of lactic acid bacteria in intestinal tract after intake of food containing lactic acid bacteria, second report
Scientific Title	A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. Second report, an open trial.
Scientific Title:Acronym	A study for evaluating the viability of lactic acid bacteria in intestinal tract after intake of food containing lactic acid bacteria, second report
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 of viable Lactobacillus brevis in the feces
Key secondary outcomes	Number of Lactobacillus genus in the feces, number of Bifidobacterium genus in the feces, number of total bacteria in the feces, organic acids content in feces, decay product content in feces

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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 59 years of age (2) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or health foods in common use, including food for specified health use and food with function claim (2) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use (3) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use and food with function claim, which influence intestinal regulation during the study period (4) Individuals presenting known food allergy (5) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (6) Individuals who are under treatment or have a history of drug/alcohol dependence (7) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (8) Individuals who are judged as unsuitable for the study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Keishiro Middle name Last name Yoshida
Organization	Lotte Co., Ltd.
Division name	Central Laboratory
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0275
Email	yoshida_keishirou@lotte.co.jp

Public contact
Name of contact person	1st name Keishiro Middle name Last name Yoshida
Organization	Lotte Co., Ltd.
Division name	Central Laboratory
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0275
Homepage URL
Email	yoshida_keishirou@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Nihonbashi Cardiology Clinic
Address	13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.jp

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	2018 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 12 Month 05 Day
Date of IRB	2018 Year 12 Month 05 Day
Anticipated trial start date	2018 Year 12 Month 14 Day
Last follow-up date	2019 Year 02 Month 18 Day
Date of closure to data entry	2019 Year 03 Month 21 Day
Date trial data considered complete	2019 Year 04 Month 03 Day
Date analysis concluded	2019 Year 04 Month 16 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 13 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040153