UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of intestinal action by intake of lactic acid bacteria (killed bacteria)
Title of the study (Brief title)	Verification of intestinal action
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A placebo-controlled double-blind study was conducted to verify the intestinal action due by intake of lactic acid bacteria (killed bacteria). We performed intestinal flora analysis (TRFLP/quantitative PCR), fecal organic acid analysis, fecal decomposition product analysis, fecal ammonia measurement, fecal pH measurement, fecal water content measurement, bowel survey (bowel movement and feculent) and evaluated effectiveness.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bowel survey (bowel movement, feculent)
Key secondary outcomes	Intestinal flora analysis Fecal organic acids analysis Fecal spoilage product analysis Fecal ammonia measurement Fecal pH measurement Fecal water content measurement Intestinal flora analysis (quantitative PCR) 6 primer

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test food1(lactic acid bacteria) 1 package once Take the test article with a glass of water within 30 minutes after breakfast. If you forget, take it during the day. Do not carry over if you can not take it during the day.2 weeks consumption.
Interventions/Control_2	Test food2(lactic acid bacteria) 1 package once Take the test article with a glass of water within 30 minutes after breakfast. If you forget, take it during the day. Do not carry over if you can not take it during the day.2 weeks consumption.
Interventions/Control_3	Placebo food (not containing lactic acid bacteria) 1 package once Take the test article with a glass of water within 30 minutes after breakfast. If you forget, take it during the day. Do not carry over if you can not take it during the day.2 weeks consumption.
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Japanese males and females aged 20 to 59 years old at the time of acquiring consent on the first observation day (including screening) 2) Persons who have 3 to 5 times of bowel movement per week
Key exclusion criteria	1) Persons who are taking medications (antibiotics, drugs with intestinal action, etc.) that are likely to affect the test results 2) Persons routinely taking health foods (such as supplements expressing intestinal action, etc.) that are likely to affect the test results 3) During pregnancy or possibly pregnant, and those who are breastfeeding 4) Alcohol addiction 5) Persons who are likely to have allergic symptoms depending on the test article component 6) Participating in other clinical trials 7) Persons who have a history of serious liver disorder, kidney disorder, heart disease 8) Persons who have a history of hepatitis or who are currently suffering from hepatitis 9) Persons with serious anemia
Target sample size	60

Research contact person
Name of lead principal investigator	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	Ko Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	Nissin Foods Holdings 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 12 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 23 Day
Anticipated trial start date	2017 Year 03 Month 28 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 12 Month 11 Day
Last modified on	2017 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031624