UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053123 |
|---|---|
| Receipt number | R000060619 |
| Scientific Title | Food Verification test for cold symptoms in children |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2023/12/15 16:31:20 |
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Basic information
Public title
Food Verification test for cold symptoms in children
Acronym
Food Verification test for cold symptoms in children
Scientific Title
Food Verification test for cold symptoms in children
Scientific Title:Acronym
Food Verification test for cold symptoms in children
Region
| Japan |
Condition
Condition
Children
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the test food on cold symptoms in children will be evaluated by continuous intake of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cold symptoms
Body temperature
Number of sick days at kindergartens and elementary schools
Number of hospital visit not including regular hospital visits
Key secondary outcomes
Lifestyle survey, measurement of state of mind using voice recognition app
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food (high dose) for 8 weeks
Interventions/Control_2
Ingestion of test food (low dose) for 8 weeks
Interventions/Control_3
Ingestion of placebo food for 8 weeks
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
| 3 | years-old | <= |
Age-upper limit
| 9 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy children over 3 years old and under 8 years old
2.The subject and the subject's parents or legal guardians have fully understood the purpose and content of this study, and the subject and the subject's parents or legal guardian have voluntarily agreed to participate in the study. Those who volunteered and agreed to participate in writing Subjects whose written informed consent has been obtained
Key exclusion criteria
1.Liver disease, kidney disease, digestive system disease, respiratory disease, heart disease, blood disease, endocrine and metabolic disease, etc. Persons with a history of other diseases that may affect the results of this study, or a history of surgery someone with
2.Persons with a disease that requires constant medication or a history of a serious disease that requires medication treatment
3.Persons with food or drug allergies
4.Persons who regularly consume functional foods and supplements that may prevent cold symptoms.
5.Persons who engage in strenuous sports or are on a diet.
6.Persons who have participated in a clinical trial or long-term clinical trial for beverages or cosmetics within the past 4 weeks; and those currently participating in clinical trials.
7.Others who are deemed inappropriate by the study director
Target sample size
45
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
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Nakashima |
Organization
Euglena Co., Ltd.
Division name
Lifescience Research Institute
Zip code
108-0014
Address
5-29-11 G-BASE Tamachi 2nd and 3rd floor, Shiba, Minato-ku, Tokyo
TEL
03-3453-4907
Homepage URL
nakashima@euglena.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
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
| 2024 | Year | 12 | Month | 31 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060619
