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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004085
Receipt No. R000004922
Scientific Title Synbiotic therapy for patients on long term mechanical ventilation support
Date of disclosure of the study information 2010/08/23
Last modified on 2010/08/22

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Basic information
Public title Synbiotic therapy for patients on long term mechanical ventilation support
Acronym Synbiotic therapy for patients on long term mechanical ventilation support
Scientific Title Synbiotic therapy for patients on long term mechanical ventilation support
Scientific Title:Acronym Synbiotic therapy for patients on long term mechanical ventilation support
Region
Japan

Condition
Condition patients on long term mechanical ventilation support
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective was to investigate the effect of the colonization of Pseudomonas aeruginosa, fecal organic acids, and gut flora by synbiotic therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes amount of the colonization of Pseudomonas aeruginosa, changese of fecal organic acids and gut flora.
Key secondary outcomes

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 Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Patients in the synbiotic group were administrated Lactobacillus casei strain Shirota, Bifidobacterium breve strain Yakult, and galactooligosaccharides as synbiotics for 8 weeks.
Interventions/Control_2 Patients in control groups were not administered any of these synbiotics.
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 The present study included patients who received mechanical ventilation support and administration of enteral tube feeding for more than one month
Key exclusion criteria Patients were excluded if they were under 18 years of age or had a terminal illness. Patients who had received selective digestive decontamination, or prebiotic and probiotic therapies were also excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineji Hayakawa
Organization Hokkaido University Hospital
Division name Emergency and Critical Care Center
Zip code
Address N14W5 Kita-ku, Sapporo 060-8648 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hokkaido University Hospital
Division name Emergency and Critical Care Center
Zip code
Address
TEL
Homepage URL
Email mineji@dream.com

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
Organization
Division
Category of Funding Organization Other
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
2010 Year 08 Month 23 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 Completed
Date of protocol fixation
2008 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 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
2010 Year 08 Month 22 Day
Last modified on
2010 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004922

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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