UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007114 |
|---|---|
| Receipt number | R000008365 |
| Scientific Title | Study of the induction of cytokines by the intake of lactobacillus. |
| Date of disclosure of the study information | 2012/01/22 |
| Last modified on | 2012/07/24 18:13:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the induction of cytokines by the intake of lactobacillus.
Acronym
Study of the induction of cytokines by lactobacillus.
Scientific Title
Study of the induction of cytokines by the intake of lactobacillus.
Scientific Title:Acronym
Study of the induction of cytokines by lactobacillus.
Region
| Japan |
Condition
Condition
No (healthy donor)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect in the expression levels of cytokine related to cancer prevention effect through oral intake lactobacillus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of expression of specific cytokine related to cancer prevention in plasma, saliva, urine and PBMC from the participants after intervention with/without lactobacilli
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
control (starch tablet)
intake one tablet per day for four weeks
Interventions/Control_2
five hundred-millions of lactobacilli in one tablet
intake one tablet per day for four weeks
Interventions/Control_3
fifteen hundred-millions of lactobacilli in one tablet
intake one tablet per day for four weeks
Interventions/Control_4
forty-five hundred-millions of lactobacilli in one tablet
intake one tablet per day for four weeks
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
Healthy adult men and women
Key exclusion criteria
1. people with chronic diseases (allergic disease, hypertension, hypotension, diabetes, hyperuricemia, chronic bronchitis, emphysema pulmonum, thyroid deficiency, osteoporosis, angina, chronic hepatitis, chronic pancreatitis, rheumatism)
2. people while taking (lactobacillus preparation, immune-suppressing drug)
3. women in pregnancy, woman of child-bearing potential or lactating woman
4. people in a clinical trial or in passing not over four weeks from end of clinical trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sakai |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5338
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5338
Homepage URL
Sponsor or person
Institute
Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Suntory Holdings Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
京都府立医科大学(京都府)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 22 | 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
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 22 | Day |
Last modified on
| 2012 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008365
