UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033035
Receipt number R000037539
Scientific Title Examination of suppression effects of a Lactic acid bacteria EF2001 on Candida fungus
Date of disclosure of the study information 2018/06/30
Last modified on 2018/06/18 15:47:34

* 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

Examination of suppression effects of a Lactic acid bacteria EF2001 on Candida fungus

Acronym

Suppression effect of EF2001 on Candida fungus

Scientific Title

Examination of suppression effects of a Lactic acid bacteria EF2001 on Candida fungus

Scientific Title:Acronym

Suppression effect of EF2001 on Candida fungus

Region

Japan


Condition

Condition

Oral candidiasis

Classification by specialty

Oral surgery Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Exploration of inhibitory effect of Candida by ingesting lactic acid bacteria (EF 2001).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[Before administration and one week after starting administration]
Candida bacteria test

Key secondary outcomes

[ Before administration ]
Background survey : gender / date of birth / age / past history / complications, drugs used, regular specified health food, health food, functional display food etc.

[Before administration and one week after starting administration]
Saliva quantity test
Questionnaire on subjective symptoms


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake powdery test food containing 75 billion lactic acid bacteria (EF 2001) with water or lukewarm water before sleeping once a day,and continue for 1 week.

Interventions/Control_2


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

40 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Those who tend to have less salivation.
(2) Adult males and females aged 40 to 80 at the time of acquisition.
(3) A person who received the explanation of the relevant clinical trial in advance, can understand its contents, obtains document consent by the person himself / herself.

Key exclusion criteria

(1) Those who are ongoing treatment with drugs.
(2) Those who routinely consume medicines, foods for specified health use, health foods, functional display foods, etc. that are likely to affect the test results.
(3) Person who has a history of severe disease (cancer etc) and history of current in heart, liver, kidney, gastrointestinal etc.
(4) Those during pregnancy, breast-feeding during the study period, or those who wish for pregnancy during the period.
(5) Persons whose eating habits are extremely irregular, such as shift workers or late night workers whose life rhythms are irregular.
(6) Persons who are allergic to pharmaceuticals and foods (especially test foods).
(7) Participating in clinical trials of other medicinal products or health foods, those within 4 weeks after the examination or those who intend to participate in other clinical trials after participating in the study.
(8) Who are judged inappropriate to participate in the exam by the investigator dentist or a sub investigator dentist.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Saito Ichiro

Organization

Tsurumi-University School of Dental Medicine

Division name

Department of Pathology

Zip code


Address

2-1-3 Tsurumi-ku, Yokohama-shi, Kanagawa, Japan

TEL

+81-45-580-8360

Email

saito-i@tsurumi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Saito Ichiro

Organization

Tsurumi-University School of Dental Medicine

Division name

Department of Pathology

Zip code


Address

2-1-3 Tsurumi-ku, Yokohama-shi, Kanagawa, Japan

TEL

+81-45-580-8360

Homepage URL


Email

saito-i@tsurumi-u.ac.jp


Sponsor or person

Institute

KANEROKU Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

KANEROKU Pharmaceutical 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

鶴見大学歯学部附属病院 / Tsurumi University Dental Hospital
白根歯科クリニック / Shirone Dental Clinic


Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 30 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 04 Month 21 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 22 Day

Last follow-up date

2017 Year 08 Month 04 Day

Date of closure to data entry

2017 Year 08 Month 09 Day

Date trial data considered complete

2017 Year 08 Month 09 Day

Date analysis concluded

2018 Year 01 Month 17 Day


Other

Other related information



Management information

Registered date

2018 Year 06 Month 18 Day

Last modified on

2018 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037539


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name