UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050653 |
|---|---|
| Receipt number | R000057701 |
| Scientific Title | Elucidation of metabolic and immune programing by placenta and prenatal exposure to maternal gut environmental factors - Elucidation of Life Phenomena in Early Life Stages for Improvement of Health and Medical Care(Analysis of correlation between maternal intestinal environment and health status of mother and child) - |
| Date of disclosure of the study information | 2023/03/23 |
| Last modified on | 2023/06/13 10:52:57 |
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Basic information
Public title
Elucidation of metabolic and immune programing by placenta and prenatal exposure to maternal gut environmental factors - Elucidation of Life Phenomena in Early Life Stages for Improvement of Health and Medical Care(Analysis of correlation between maternal intestinal environment and health status of mother and child) -
Acronym
Elucidation of metabolic and immune programing by placenta and prenatal exposure to maternal gut environmental factors
Scientific Title
Elucidation of metabolic and immune programing by placenta and prenatal exposure to maternal gut environmental factors - Elucidation of Life Phenomena in Early Life Stages for Improvement of Health and Medical Care(Analysis of correlation between maternal intestinal environment and health status of mother and child) -
Scientific Title:Acronym
Elucidation of metabolic and immune programing by placenta and prenatal exposure to maternal gut environmental factors
Region
| Japan |
Condition
Condition
pregnant woman and newborn baby
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidation of metabolic imprinting and immune system of uterus influenced by maternal gut microbiota
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elucidation of the role of maternal gut microbiota that influence maternal and infant condition and immune system of uterus
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant woman scheduled cesarean section
Key exclusion criteria
under 20 years old
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ito |
Organization
Hamamatsu University school of medicine
Division name
obstetrics and gynecology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Shizuoka Prefecture
TEL
0534352309
hitou-end@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ito |
Organization
Hamamatsu University school of medicine
Division name
obstetrics and gynecology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Shizuoka Prefecture
TEL
0534352309
Homepage URL
hitou-end@umin.ac.jp
Sponsor or person
Institute
Hamamatsu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University school of medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Shizuoka Prefecture
Tel
0534352309
rinri@hama-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
| 2023 | Year | 03 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Literature search was conducted on 31/3/2021.
Sample collection is scheduled to continue through 31/3/2024.
Statistical analyses will be done by 3/31/2026.
Management information
Registered date
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057701
