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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041088
Receipt No. R000046922
Scientific Title Evaluation of effects on oral micro-flora by continuous intake of jelly made sea cucumber.
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/13

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Basic information
Public title Evaluation of a jelly food made from sea cucumber on improvement of oral health.
Acronym Evaluation tests of sea cucumber jelly.
Scientific Title Evaluation of effects on oral micro-flora by continuous intake of jelly made sea cucumber.
Scientific Title:Acronym Effects on oral micro-flora by sea cucumber jelly intake.
Region
Japan

Condition
Condition Oral candidiasis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We attempt to assess the positive effects of continuous intake of jelly food made from sea cucumber on oral micro flora.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes After daily intake of test food for 2 weeks, the followings are assessed;
Oral streptococci amounts
Oral Candida amounts
Oral wetness
Oral Health Assessment Tool score
BMI <Body Mass Index>
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Test group: Taking test food twice a day for 2 weeks.
Interventions/Control_2 Control group: Taking placebo food twice a day for 2 weeks.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Institutionalized elderly who take food by mouth.
Key exclusion criteria Individuals assessed to be unsuitable for research participation by the facility staff.
Individuals who have low consent ability and cannot obtain consent from the main caregiver.
Individuals who refuses the test in spite of consent the main caregiver.
Individuals who are judged to be difficult by the facility staff to participate due to poor physical condition on the day of the survey.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name MITSUO
Middle name
Last name KISHI
Organization Iwate Medical University School of Dentistry
Division name Division of Preventive Dentistry, Department of Oral Medicine
Zip code 0208505
Address 1-3-27 Chuo-Dori, Morioka, Iwate prefecture
TEL 019-651-5111
Email mkishi@iwate-med.ac.jp

Public contact
Name of contact person
1st name MITSUO
Middle name
Last name KISHI
Organization Iwate Medical University School of Dentistry
Division name Division of Preventive Dentistry, Department of Oral Medicine
Zip code 0208505
Address 1-3-27 Chuo-Dori, Morioka, Iwate prefecture
TEL 019-651-5111
Homepage URL
Email mkishi@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University School of Dentistry
Institute
Department

Funding Source
Organization Iwate prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Iwate Medical University School of Dentistry
Address 1-3-27 Chuo-Dori, Morioka, Iwate prefecture
Tel 019-651-5111
Email takashi.kondou@j.iwate-med.ac.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 10 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 13 Day
Last modified on
2020 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046922

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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