UMIN-CTR Clinical Trial

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 Watanabe Middle name Last name Yuna
Organization	Niigata University of Health and Welfare
Division name	Department of Health and Nutrition
Zip code	950-3198
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 Fujinami Middle name Last name Misa
Organization	Natural Science Co.,Ltd.
Division name	Research and Development Department
Zip code	136-0073
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	Niigata University of Health and Welfare IRB
Address	1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
Tel	025-257-4455
Email	eri-sakata@nuhw.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	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	35
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	2017 Year 12 Month 26 Day
Date of IRB	2018 Year 01 Month 17 Day
Anticipated trial start date	2018 Year 03 Month 15 Day
Last follow-up date	2021 Year 03 Month 31 Day
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	2021 Year 04 Month 12 Day

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