UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030350 |
|---|---|
| Receipt number | 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 16:07:58 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031624
