UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023452 |
|---|---|
| Receipt number | R000026878 |
| Scientific Title | Effects of Lactobacillus GG probiotics on the enterobacterial flora in patients with hematological diseases |
| Date of disclosure of the study information | 2017/08/02 |
| Last modified on | 2017/08/20 13:52:23 |
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Basic information
Public title
Effects of Lactobacillus GG probiotics on the enterobacterial flora in patients with hematological diseases
Acronym
Effects of LGG probiotics on patients with hematological diseases
Scientific Title
Effects of Lactobacillus GG probiotics on the enterobacterial flora in patients with hematological diseases
Scientific Title:Acronym
Effects of LGG probiotics on patients with hematological diseases
Region
| Japan |
Condition
Condition
Hematological diseases
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Lactobacillus GG probiotics on the enterobacterial flora in patients with hematological diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effects of LGG probiotics on composition and diversity of the enterobacterial flora evaluated with next-generation sequencer
Key secondary outcomes
Effects of LGG probiotics on viable bacteria, including multidrug-resistant strains, evaluated with fecal culture.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will take a pack of test yogult at lunchtime for 2 weeks.Fecal samples will be analyzed before and once a week thereafter until hospital discharge.
Interventions/Control_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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hematological diseases who are staying at East-9 ward of Osaka Saiseikai Nakatsu Hospital, who are expected to stay in the hospital for additional seven or more days, and who agreed and signed to the letter of consent.
Key exclusion criteria
Patients who have experienced severe adverse events by taking dairy products, or in whom oral intake is contraindicated due to clinical conditions.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensuke Ohta |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Department of Hematology
Zip code
Address
2-10-39 Shibata Kitaku Osaka city
TEL
06-6372-0333
kenohta@nakatsu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ohta |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Department of Hematology
Zip code
Address
2-10-39 Shibata Kitaku Osaka city
TEL
06-6372-0333
Homepage URL
kenohta@nakatsu.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Nakatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Saiseikai Nakatsu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takanashi Milk co.ltd
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
| 2017 | Year | 08 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 08 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 06 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2017 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026878
