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

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 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


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

Value
https://center6.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