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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029452
Receipt No. 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

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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
Email 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
Email takurou_ueki@n1.noevir.co.jp

Sponsor
Institute Kobe College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033652

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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