UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between perinatal FOXP3 positive T cells and histone deacetylase
Title of the study (Brief title)	Relationship between perinatal regulatory T cells and epigenetics
Region	Japan

Condition
Condition	Allergy/Immunology
Classification by specialty	Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identify factors related to perinatal regulatory T cell expression
Basic objectives2	Others
Basic objectives -Others	Identify factors related to perinatal regulatory T cell expression
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Find differences in HDAC inhibitory capacity between adults and umbilical cord blood
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	1 days-old <=
Age-upper limit	6 days-old >
Gender	Male and Female
Key inclusion criteria	normal term infant
Key exclusion criteria	Exclusion criteria were preterm deliveries, multiple gestation (twins, triplets), perinatal infections including fever around birth, maternal intake of medication, and maternal chronic diseases
Target sample size	20

Research contact person
Name of lead principal investigator	Yamazaki Susumu
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Pediatrics and Adolescent Medicine
Address	3-1-3, Hongo,Bunkyo, Tokyo
TEL	0338133111
Email	susumu@juntendo.ac.jp

Public contact
Name of contact person	Susumu Yamazaki
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Pediatrics and Adolescent Medicine
Address	3-1-3, Hongo,Bunkyo, Tokyo
TEL	0338133111
Homepage URL
Email	susumu@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	This work was supported by KAKENHI (Grants-in-Aid for Scientific Research from the Japanese Ministry of Education, Culture, Sports Science and Technology; 16K19667).
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JPN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	順天堂大学附属順天堂静岡病院、順天堂大学順天堂医院

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	After approval of the ethics committee, the ability to inhibit histone acetylation of umbilical cord blood serum of normal newborn was examined.

Management information
Registered date	2019 Year 03 Month 04 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041100