UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011065 |
|---|---|
| Receipt number | R000012946 |
| Scientific Title | Prophylaxis of febrile neutropenia by reducing chemotherapy-induced gastrointestinal mucosal injury |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2017/07/08 12:40:43 |
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Basic information
Public title
Prophylaxis of febrile neutropenia by reducing chemotherapy-induced gastrointestinal mucosal injury
Acronym
Prophylaxis of febrile neutropenia
Scientific Title
Prophylaxis of febrile neutropenia by reducing chemotherapy-induced gastrointestinal mucosal injury
Scientific Title:Acronym
Prophylaxis of febrile neutropenia
Region
| Japan |
Condition
Condition
febrile neutropenia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent febrile neutropenia in pediatric patients undergoing chemotherapy for malicnancies with prophylactic use of synbiotics and glutamine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
incidence of febrile neutropenia
Key secondary outcomes
severity of gastrointestinal mucosal
injury
stability of intestinal environments
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
oral administration of synbiotics
Interventions/Control_2
oral administration of glutamine
Interventions/Control_3
oral administration of synbiotics and glutamine
Interventions/Control_4
control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | months-old | <= |
Age-upper limit
| 216 | months-old | > |
Gender
Male and Female
Key inclusion criteria
patients admitted for cancer chemotherapy which is expected to cause neutropenia
Key exclusion criteria
patients with underlying infection before developping neutropenia
patients who is allergic to probiotics or glutamine
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Shimizu |
Organization
Juntendo University School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo , Japan
TEL
03-3813-3111
tkurashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Kurimoto |
Organization
Juntendo University School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo , Japan
TEL
03-3813-3111
Homepage URL
tkurashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Yakult Central Institute for Microbiological Research
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
順天堂大学医学部附属順天堂医院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | 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
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 24 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012946
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
