UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015983 |
|---|---|
| Receipt number | R000018591 |
| Scientific Title | Involvement of microflora in host immune responses after respiratory syncytial virus infections |
| Date of disclosure of the study information | 2014/12/20 |
| Last modified on | 2014/12/17 20:06:06 |
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Basic information
Public title
Involvement of microflora in host immune responses after respiratory syncytial virus infections
Acronym
Involvement of microflora in host immune responses after respiratory syncytial virus infections
Scientific Title
Involvement of microflora in host immune responses after respiratory syncytial virus infections
Scientific Title:Acronym
Involvement of microflora in host immune responses after respiratory syncytial virus infections
Region
| Japan |
Condition
Condition
RSV infectious diseases
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal that antibiotics effect microflora.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of microflora
Key secondary outcomes
The change of host immune response to RSV infectious diseases.
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
| 0 | years-old | <= |
Age-upper limit
| 1 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The hospitalized children who don't take antibiotics within 2 weeks.
Key exclusion criteria
Patients who are apropriate to being injected Paribizmab.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naruhiko Ishiwada |
Organization
Medical Mycology Research Center, Chiba University
Division name
Division of Infection control and prevention
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8673 Japan
TEL
0432227171
ishiwada@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koo Nagasawa |
Organization
Chiba University
Division name
Pediatrics
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8673 Japan
TEL
043-222-7171
Homepage URL
adpa2753@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2014 | Year | 12 | Month | 20 | 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
| 2014 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sampling for case control
Management information
Registered date
| 2014 | Year | 12 | Month | 17 | Day |
Last modified on
| 2014 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018591
