UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029440 |
|---|---|
| Receipt number | R000033637 |
| Scientific Title | The study of probiotic supplementation for prophylaxis of infectious disorder including acute colitis in hematological malignancies |
| Date of disclosure of the study information | 2017/10/06 |
| Last modified on | 2023/04/11 15:39:23 |
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Basic information
Public title
The study of probiotic supplementation for prophylaxis of infectious disorder including acute colitis in hematological malignancies
Acronym
Probiotic supplementation for prophylaxis
of infectious disorder in hematological malignancies
Scientific Title
The study of probiotic supplementation for prophylaxis of infectious disorder including acute colitis in hematological malignancies
Scientific Title:Acronym
Probiotic supplementation for prophylaxis
of infectious disorder in hematological malignancies
Region
| Japan |
Condition
Condition
Acute leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate an efficacy of probiotics for prophylaxis of infection in hematological malignancies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)The frequencies or severity of gastrointestinal complication and febrile neutropenia
2)The frequencies or severity of bacterial colitis and sepsis
Key secondary outcomes
The effect of probiotics supplementation
in comparison with historical control
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention/Through-out of anti-cancer
treatment
Interventions/Control_2
Control group with no suppelementation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Tha cases of acute myeloid or lymphoid leukemia undergoing induction or consolidation chemotherapy
Key exclusion criteria
Nothing paticular
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Hagihara |
Organization
Eiju General Hospital
Division name
Division of Hematology
Zip code
1108645
Address
2-23-16 Higashiueno Taito-ku Tokyo
TEL
0338338381
hagihara@eijuhp.com
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Hagihara |
Organization
Eiju General Hospital
Division name
Division of Hematology
Zip code
1108645
Address
2-23-16 Higashiueno Taito-ku Tokyo
TEL
0338338381
Homepage URL
hagihara@eijuhp.com
Sponsor or person
Institute
Eiju General Hospital
Institute
Department
Personal name
Funding Source
Organization
Eiju General Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Eiju General Hospital
Address
2-23-16,Higashi-Ueno,Taito-ku
Tel
81338338381
hagihara@eijuhp.com
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
| 2017 | Year | 10 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Progress in analysis
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033637
