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
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
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
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
