UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052794 |
|---|---|
| Receipt number | R000060249 |
| Scientific Title | Pediatric safety test of processed foods from plant: An exploratory clinical trial |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2023/11/14 11:17:15 |
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Basic information
Public title
Safety test of the food
Acronym
Safety test of the food
Scientific Title
Pediatric safety test of processed foods from plant: An exploratory clinical trial
Scientific Title:Acronym
Safety test of the food
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pediatric safety of the processed foods from plant.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of adverse events during the period of consumption of the test food (excluding adverse events determined to be poorly related to the consumption of the test food)
Key secondary outcomes
-TEWL value
-Stratum corneum moisture content
-Skin surface image
-Skin color image
-Blood test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the processed foods from plant once a day for 8wks.
Interventions/Control_2
No intake
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
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Infants aged 1-3
2. Infants for whom written consent to participate in this study has been obtained from parent/guardian
3. Infants whose parents have a history of allergic diseases (food allergy, bronchial asthma, atopic dermatitis, allergic rhinitis or hay fever, conjunctivitis, etc.) in the past
Key exclusion criteria
1. Infants currently suffering from infections that are presumed to interfere with study performance, such as dyskeratosis, blistering, pneumonia, and certain viral infections
2. Infants who have been diagnosed by a physician as having an allergic disease (food allergy, bronchial asthma, atopic dermatitis, allergic rhinitis or hay fever, conjunctivitis, etc.) in the past
3. Infants born at a gestational age of less than 37 weeks
4. Infants who has low birth weight (<2500g)
5. Multiple fetuses
6. Infants who have had allergic reactions in the past to amanino, sesame, or other edible oils
7. Infants with a habit of continuous consumption of amani-oil and sesame oil
8. Infants whom the principal researcher or researcher in charge determines to be inappropriate as subjects of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Shimizu |
Organization
Juntendo University School of Medicine Juntendo Clinic
Division name
Pediatrics and Adolescent Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN
TEL
+81-3-3813-3111
inaemon@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Shimizu |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-80-7614-3911
Homepage URL
shimizu.yuki4@kao.com
Sponsor or person
Institute
Juntendo University School of Medicine Juntendo Clinic
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
C&C Qualitative Interview Institute, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Science Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN
Tel
+81-3-5802-1584
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E0039-2308
Org. issuing International ID_1
Kao Corporation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 17 | 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
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060249
