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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033035
Receipt No. 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

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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
Institute KANEROKU Pharmaceutical Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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