UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004085 |
|---|---|
| Receipt number | 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 22:43:40 |
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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
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
mineji@dream.com
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004922
