UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018439 |
|---|---|
| Receipt number | R000021351 |
| Scientific Title | Sterilized lactobacillus in prophylaxis against febrile neutropenia in pediatric acute lymphoblastic leukemia :A multi-center,open label, crossover study |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2018/11/27 17:12:57 |
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Basic information
Public title
Sterilized lactobacillus in prophylaxis against febrile neutropenia in pediatric acute lymphoblastic leukemia :A multi-center,open label, crossover study
Acronym
Sterilized lactobacillus in prophylaxis against FN in pediatric ALL
Scientific Title
Sterilized lactobacillus in prophylaxis against febrile neutropenia in pediatric acute lymphoblastic leukemia :A multi-center,open label, crossover study
Scientific Title:Acronym
Sterilized lactobacillus in prophylaxis against FN in pediatric ALL
Region
| Japan |
Condition
Condition
febrile neutropenia in pediatric acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
prophylactic use of sterilized lactobacillus in febrile neutropenia with pediatric acute lymphoblastic leukemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
days of febrile neutropenia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
sterilized lactobacillus while protcol III-1
Interventions/Control_2
sterilized lactobacillus while protcol III-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 | years-old | <= |
Age-upper limit
| 19 | years-old | > |
Gender
Male and Female
Key inclusion criteria
JPLSG ALL-B12 standard risk patients
Key exclusion criteria
allergy for lactobacillus
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Shimojo |
Organization
Graduate school of medicine, Chiba university
Division name
Department of pediatrics
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
shimojo@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Moeko Hino |
Organization
Graduate school of medicine, Chiba university
Division name
Department of pediatrics
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
Homepage URL
moekohino@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
donation
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021351
