UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029452 |
|---|---|
| Receipt number | R000033652 |
| Scientific Title | Effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation of younger women |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2018/04/09 08:58:31 |
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Basic information
Public title
Effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation of younger women
Acronym
Effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation of younger women
Scientific Title
Effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation of younger women
Scientific Title:Acronym
Effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation of younger women
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine/verify the effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gastrointestinal flora
Key secondary outcomes
IgA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Placebo control (without bifidobacteria)
(Name of constituent) Potato starch, calcium stearate, and hydroxypropyl methylcellulose
Interventions/Control_2
Bifidobacterium supplement (with viable bifidobacteria)
(Name of constituent) Viable bifidobacteria, potato starch, calcium stearate, and hydroxypropyl methylcellulose
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
Female
Key inclusion criteria
(1) The age at the time of obtaining a consent is 20 years or older.
(2) Female
(3) Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria
The person who is unsuitable for the entry judged by a officer.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Takaoka |
Organization
Kobe College
Division name
School of Human Sciences, Department of Biosphere Sciences
Zip code
Address
4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan
TEL
0798-51-8668
takaoka@mail.kobe-c.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takurou Ueki |
Organization
Noevir Co., Ltd.
Division name
Groupwide Research and Development
Zip code
Address
R&D C Building No. 333, Kanagawa Science park (KSP), 3-2-1 Sakado, Takatsu-ku, Kawasaki-shi, Kanagaw
TEL
044-813-2488
Homepage URL
takurou_ueki@n1.noevir.co.jp
Sponsor or person
Institute
Kobe College
Institute
Department
Personal name
Funding Source
Organization
Noevir Co., Ltd.
DAC Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
神戸女学院大学（兵庫県）
Kobe College（Hyogo Prefecture）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 15 | 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 | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 14 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 06 | Day |
Last modified on
| 2018 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033652
