UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041935 |
|---|---|
| Receipt number | R000047826 |
| Scientific Title | Examination of the effects of Euglena intake by young children |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2021/09/01 13:26:56 |
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Basic information
Public title
Examination of the effects of Euglena intake by young children
Acronym
Examination of the effects of Euglena intake by young children
Scientific Title
Examination of the effects of Euglena intake by young children
Scientific Title:Acronym
Examination of the effects of Euglena intake by young children
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination the effects of the test food on atopic dermatitis, bowel movement, sleep quality and quality of life in young children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Atopic Dermatitis dermatitis symptoms (subjective and objective parameters)
Safety (harmful events, urine items)
Bowel status
Key secondary outcomes
Physical condition
Physical examination
DHEA-S in saliva
Melatonin in saliva
Electroencephalogram during sleep
Autonomic nerves activities during sleep
Attention test
Questionnaires (oral cavity, health condition, basic lifestyle, sociality)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Euglena Gracilis powder-containing drink
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy infant subjects aged 1 to 6 years
(2) Subjects suffering from atopic dermatitis
(3) Parents or legal guardians voluntarily volunteer for the subject to participate in the exam after the subject's parents or legal guardians fully understand the purpose and content of this exam
Key exclusion criteria
(1) Persons with a history of other diseases that may affect the results of this study, such as liver disease, renal disease, digestive system disease, respiratory disease, heart disease, blood disease, endocrine and metabolism, or surgery History subjects
(2) Persons with a disease requiring constant medication, subjects with a history of serious illness requiring medication
(3) Subjects with food and drug allergies
(4) Subject who routinely ingests functional foods and supplements that may affect the excretion of harmful substances in the body
(5) Those who play intense sports and subjects who are on a diet
(6) Subjects who have participated in clinical trials or long-term clinical trials of foods and cosmetics within 4 weeks, and subjects who are currently participating in clinical trials
(7) Other subjects judged by the investigator to be inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka,Osaka
TEL
0661355200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
0648018917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
euglena 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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
0661355200
mterashima@oneness-sup.co.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
医療法人花音会みうらクリニック
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047826
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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