UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of suppression effects of a Lactic acid bacteria EF2001 on Candida fungus
Title of the study (Brief title)	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	Saito Ichiro
Organization	Tsurumi-University School of Dental Medicine
Division name	Department of Pathology
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	Saito Ichiro
Organization	Tsurumi-University School of Dental Medicine
Division name	Department of Pathology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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