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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name