UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047462 |
|---|---|
| Receipt number | R000054122 |
| Scientific Title | Effects of childcare amongst the nature: Stress response and gut microbiota. |
| Date of disclosure of the study information | 2022/04/12 |
| Last modified on | 2023/09/19 18:29:22 |
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Basic information
Public title
Effects of childcare amongst the nature: Stress response and gut microbiota.
Acronym
Effects of childcare amongst the nature: Stress response and gut microbiota.
Scientific Title
Effects of childcare amongst the nature: Stress response and gut microbiota.
Scientific Title:Acronym
Effects of childcare amongst the nature: Stress response and gut microbiota.
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of childcare amongst the nature on childhood stress.
A Randomized Controlled Trial on the Effect of Environmental Richness on Gastrointestinal Symptoms in Early Childhood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Children's gastrointestinal symptoms are comprehensively assessed in the Children's Somatization Inventory (CSI) 4 weeks after the start of the natural childcare intervention.
Key secondary outcomes
We will evaluate changes in children's behavior, intestinal microbiota, amylase, cortisol and sleep time 4 weeks after the start of natural childcare intervention.
Child Behavior Checklist,Physical Activity Questionnaire Environmental Module, Parental Bonding Instrument, Outdoor Playtime Checklist
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
childcare amongst the nature(4 weeks,4 times)
Interventions/Control_2
Normal childcare(4 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
| 5 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy preschooler (age 5-6)
Key exclusion criteria
Those who have been treated with antibiotics within a month.
Those using probiotics.
Has a history of internal medicine disease and neurological disorders.
Have a history of mental illness.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Fukudo |
Organization
Tohoku University School of Medicine
Division name
Psychosomatic medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8218
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Shibata |
Organization
Tohoku University School of Medicine
Division name
Psychosomatic medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
09058382620
Homepage URL
ck-shibata@sendai-u.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 04 | Month | 12 | 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
| 2022 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054122
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
