UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041963 |
|---|---|
| Receipt number | R000047850 |
| Scientific Title | Prospective study about the effect of maternal and post-maternal periodontal disease on child's gut microbiome via breast milk |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/05/09 15:21:33 |
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Basic information
Public title
Study on the effect of mother's periodontal disease on the balance of child's gut microbiome through breast milk
Acronym
Study of the effect of mother's periodontal disease on child's gut microbiome
Scientific Title
Prospective study about the effect of maternal and post-maternal periodontal disease on child's gut microbiome via breast milk
Scientific Title:Acronym
Study of the effect of maternal and post-maternal periodontal disease on child's microbiome
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate if maternal and post-maternal periodontal disease affects child by examining child's growth, gut microbiome, mother's periodontal condition, oral microbiome, inflammatory cytokines and microbiome of breast milk.
Basic objectives2
Others
Basic objectives -Others
Child's growth and development
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Children's gut microbiome
Children's height, weight and head circumference
Microbiome in breast milk
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women
Having more than 15 teeth.
Key exclusion criteria
Planning to deliver child by caesarean section
Multiple pregnancies
Autoimmune disease
Diabetes
Administration of antibiotics within the past three months
Planning to administer antibiotics by one month postpartum
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Hirose |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Maternal and Women's clinic
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku Tokyo
TEL
03-5803-5322
a-kacrm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Hirose |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Maternal and Women's clinic
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku Tokyo
TEL
03-5803-5322
Homepage URL
a-kacrm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institution Ethics committee of Tokyo Medical and Dental University Medical School
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
soumu1.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
M2020-178
Org. issuing International ID_1
Institution Ethics committee of Tokyo Medical and Dental University Medical School
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
Investigation of periodontal disease: intraoral photograph, probing pocket depth, bleeding on probing, tooth mobility, plaque control record, oral microbiome (16S rRNA analysis)
Investigation of effects on breast milk by periodontal disease: inflammatory cytokines and microbiome in breast milk
Investigation of outcome: child's gut microbiome (16S rRNA analysis), height, weight and head circumference
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047850
| 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 |
