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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032181
Receipt No. R000036709
Scientific Title Study of neonates on the intestinal bacterial flora and skin conditions.
Date of disclosure of the study information 2018/04/10
Last modified on 2018/04/10

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Basic information
Public title Study of neonates on the intestinal bacterial flora and skin conditions.
Acronym Study on neonate's intestinal bacterial flora.
Scientific Title Study of neonates on the intestinal bacterial flora and skin conditions.
Scientific Title:Acronym Study on neonate's intestinal bacterial flora.
Region
Japan Asia(except Japan)

Condition
Condition Healthy neonates
Classification by specialty
Gastroenterology Pediatrics Dermatology
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationships between intestinal bacterial flora and skin conditions of neonates.
To examine the influence of difference in nutritional status during pregnancy on neonate's intestinal bacterial flora and skin conditions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intestinal bacterial flora
Key secondary outcomes Urinalysis
Skin tests for resident bacteria
Skin findings
Instrumental analysis of skin condition
Questionnaire survey

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Neonates born from a person who participated in "study of pregnant women on the interaction among intestinal bacterial flora, physical conditions and nutrition including dietary habits"
2) Neonate born at the testing facility.
3) Neonate who visits to postpartum 1 month medical examination at the testing facility.
4) Neonate whose parents gave informed consent.
Key exclusion criteria 1) Neonates with a disorder that affects the evaluation of this study.
2) Neonates judged inappropriate for the clinical trial by doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuna Watanabe
Organization Niigata University of Health and Welfare
Division name Department of Health and Nutrition
Zip code
Address 1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL 025-257-4494
Email yuna-watanabe@nuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Misa Fujinami
Organization Natural Science Co.,Ltd.
Division name Research and Development Department
Zip code
Address 3F Natural Factory Tokyo, 3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN
TEL 03-5665-2311
Homepage URL
Email m.fujinami@natural-s.jp

Sponsor
Institute Natural Science Co.,Ltd.
Research and Development Department
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Healthcare Systems Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 よしかた産婦人科 (神奈川県)
Yoshikata Obsterics and Gynecology Clinic (Kanagawa)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 10 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
2017 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Longitudinal study
Observation:Immediately after birth, one month, six months, one year.

Management information
Registered date
2018 Year 04 Month 10 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036709

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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