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 |
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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
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
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
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
