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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041963
Receipt No. 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 2020/10/01

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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
Email 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
Email a-kacrm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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