UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028742
Receipt number R000032892
Scientific Title Analysis an association between host immune response to rotavirus vaccine and intestinal flora
Date of disclosure of the study information 2017/08/21
Last modified on 2019/03/07 13:10:00

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Basic information

Public title

Analysis an association between host immune response to rotavirus vaccine and intestinal flora

Acronym

Analysis an association between host immune response to rotavirus vaccine and intestinal flora

Scientific Title

Analysis an association between host immune response to rotavirus vaccine and intestinal flora

Scientific Title:Acronym

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

1st name
Middle name
Last name Tetsushi Yoshikawa

Organization

Fujita Health University School of Medicine

Division name

Dept. of Pediatrics

Zip code


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

1st name
Middle name
Last name Tetsushi Yoshikawa

Organization

Fujita Health University School of Medicine

Division name

Dept. of Pediatrics

Zip code


Address

1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi.Japan

TEL

+81-562-93-9251

Homepage URL


Email

tetsushi@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 21 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 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032892


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name