UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014085 |
|---|---|
| Receipt number | R000016394 |
| Scientific Title | Effect of Lactobacillus brevis KB290 on constipation and on microbiota of people who tend to be constipated. |
| Date of disclosure of the study information | 2014/05/30 |
| Last modified on | 2015/05/13 08:56:08 |
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Basic information
Public title
Effect of Lactobacillus brevis KB290 on constipation and on microbiota of people who tend to be constipated.
Acronym
Effect of Lactobacillus brevis KB290 on constipation and on microbiota of people who tend to be constipated.
Scientific Title
Effect of Lactobacillus brevis KB290 on constipation and on microbiota of people who tend to be constipated.
Scientific Title:Acronym
Effect of Lactobacillus brevis KB290 on constipation and on microbiota of people who tend to be constipated.
Region
| Japan |
Condition
Condition
people tend to be constipated
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The status of bowel movement before and after the intervention with probiotics, Lactobacillus brevis KB290, as a lactic acid bacteria beverage, Labre, will be compared. Also, the effect of Labre on microbiota will be evaluated cyclopaedically using latest analysis methods and figure out the relation between microbiota and health.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency, days of defecation frequency in a week, amount of defecation, hardness of stool and amount of organic acid in stool will be measured.
Also, the amount of bacteria related
with bowel movement, which are Bacteroidaceae, Enterobacteriaceae, Streptococcaceae, Bifidobacterium genus,
Eubacterium genus, Peptostreptococcus genus, Lactobacillus genus, Clostridium perfringens and other bacteria belongs to Clostridium genus, will be measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Lactic acid beverage containing Lactobacillus brevis KB290
Interventions/Control_2
Placebo beverage
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People who meet either of the following conditions will be required.
1)Whose defecation frequency is no fewer than 2, nor more than 5.
2)Whose appearance frequency of hard
stool (stools which match Bristol scale score 1, 2 or 3) is 50% and over.
Key exclusion criteria
People who meet any of the following conditions will be excluded.
1)Who is judged as unsuitable because of having suffered a serious disease so far.
2)Who takes any kind of medicine which affect the result of the trial for habitual use.
3)Who has undergone surgery accompanied with digestive tract ablation.
4)Who has participated in another clinical trial within 1 month.
5)Who is judged unsuitable for this study by principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Yajima |
Organization
Kagome Co., Ltd.
Division name
Research & Development Division
Zip code
Address
17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL
0287-36-2935
Nobuhiro_Yajima@kagome.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kobayashi |
Organization
Kagome Co., Ltd.
Division name
Research & Development Division
Zip code
Address
17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL
0287-36-2935
Homepage URL
Akira_Kobayashi@kagome.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
transcosmos CRM okinawa Co., Ltd.
Name of secondary funder(s)
Urazoe General Hospital
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
| 2014 | Year | 05 | Month | 30 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 02 | Month | 26 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 27 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016394
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
