UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis an association between host immune response to rotavirus vaccine and intestinal flora
Title of the study (Brief title)	Analysis an association between host immune response to rotavirus vaccine and intestinal flora
Region	Japan

Condition
Condition	Infants in NICU/GCU that meet to the requirements for rotavirus vaccine.
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To elucidate an association between host immune response to rotavirus vaccine and intestinal flora in preterm infants.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between intestinal flora and fecal shedding of rotavirus and host immune response after vaccination.
Key secondary outcomes	A level of various cytokines/ chemokines, immunity factors contained in breast milk and blood.

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	6 weeks-old <=
Age-upper limit	14 weeks-old >=
Gender	Male and Female
Key inclusion criteria	1. Infants in NICU/GCU that meet to the requirements for rotavirus vaccine. 2. Parental written informed consent to participate in the study is required.
Key exclusion criteria	1. Subjects with contraindications or adverse effects. 2. Subjects who have a serious gastrointestinal surgical history or congenital gastrointestinal malformation. 3. Any other medical reasons judged by the principal investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	Tetsushi Yoshikawa
Organization	Fujita Health University School of Medicine
Division name	Dept. of Pediatrics
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi.Japan
TEL	+81-562-93-9251
Email	tetsushi@fujita-hu.ac.jp

Public contact
Name of contact person	Tetsushi Yoshikawa
Organization	Fujita Health University School of Medicine
Division name	Dept. of Pediatrics
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi.Japan
TEL	+81-562-93-9251
Homepage URL
Email	tetsushi@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	The National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN)
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Collection of breast milk, stool and blood samples before and after vaccination.

Management information
Registered date	2017 Year 08 Month 19 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032892