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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030350
Receipt No. R000031624
Scientific Title Verification of intestinal action by intake of lactic acid bacteria (killed bacteria)
Date of disclosure of the study information 2017/12/12
Last modified on 2017/12/12

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Basic information
Public title Verification of intestinal action by intake of lactic acid bacteria (killed bacteria)
Acronym Verification of intestinal action
Scientific Title Verification of intestinal action by intake of lactic acid bacteria (killed bacteria)
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
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
1st name
Middle name
Last name Ko Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2017 Year 01 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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