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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023452
Receipt No. 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

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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
Last 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
Email kenohta@nakatsu.saiseikai.or.jp

Public contact
1st 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
Email kenohta@nakatsu.saiseikai.or.jp

Sponsor
Institute Osaka Saiseikai Nakatsu Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026878

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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