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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011065
Receipt No. 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

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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
Email 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
Email tkurashi@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012946

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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