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Recruitment status Completed
Unique ID issued by UMIN UMIN000014085
Receipt No. R000016394
Official scientific title of the study 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

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Basic information
Official scientific title of the study Effect of Lactobacillus brevis KB290 on constipation and on microbiota of people who tend to be constipated.
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Nobuhiro Yajima
Organization Kagome Co., Ltd.
Division name Research & Development Division
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Email Nobuhiro_Yajima@kagome.co.jp

Public contact
Name of contact person Akira Kobayashi
Organization Kagome Co., Ltd.
Division name Research & Development Division
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Homepage URL
Email Akira_Kobayashi@kagome.co.jp

Sponsor
Institute Kagome Co., Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016394


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