UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017274
Receipt number R000020047
Scientific Title A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.
Date of disclosure of the study information 2015/04/25
Last modified on 2015/04/25 12:03:12

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Basic information

Public title

A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.

Acronym

A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.

Scientific Title

A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.

Scientific Title:Acronym

A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness and Immunological Response to Influenza Virus.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Daily questionnaire symptoms based on influenza-like illness

Key secondary outcomes

Immunological test using bloods collected before and after the intake period (10 weeks)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

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

Prevention

Type of intervention

Food

Interventions/Control_1

Lactic acid bacteria, 10 weeks consumption.

Interventions/Control_2

Placebo (not containing lactic acid bacteria), 10 weeks consumption

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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

(1)Subjects aged 30 to 60 years old.
(2)Subjects giving written informed consent.

Key exclusion criteria

(1)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
(2)Subjects taking any kind of medicine which affect the result of the trial for habitual use.
(3)Subjects daily consuming supplements or foods containing lactic acid bacteria.
(4)Pregnant women, lactating women.
(5)Alcoholics
(6)Subjects presenting known food allergy (milk allergy) and serious hay fever.
(7)Subjects attending other tests.
(8)Subjects with serious hepatic, renal, and cardiovascular dysfunction (including anamnesis).
(9)Subjects with anemic.
(10)Subjects who had received the influenza vaccination within the previous 18 months.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

Chair

Zip code


Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-5408-1590

Email

jimukyoku@mail.souken-r.com


Public contact

Name of contact person

1st name
Middle name
Last name Ko Masuda

Organization

SOUKEN Co., Ltd

Division name

Management Division

Zip code


Address

3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-5408-1555

Homepage URL


Email

k_masuda@mail.souken-r.com


Sponsor or person

Institute

Shiba Palace Clinic

Institute

Department

Personal name



Funding Source

Organization

Kirin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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

芝パレスクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 25 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

2012 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 25 Day

Last modified on

2015 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020047


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name