UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032181
Receipt number 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 2021/04/12 10:27:19

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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 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 or person

Institute

Natural Science Co.,Ltd.
Research and Development Department

Institute

Department

Personal name



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

Value
https://center6.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