Unique ID issued by UMIN | UMIN000006431 |
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Receipt number | R000007633 |
Scientific Title | The research of the effects of synbiotics for critically ill patients |
Date of disclosure of the study information | 2011/09/29 |
Last modified on | 2012/09/29 12:24:30 |
The research of the effects of synbiotics for critically ill patients
The research of the effects of synbiotics for critically ill patients
The research of the effects of synbiotics for critically ill patients
The research of the effects of synbiotics for critically ill patients
Japan |
critically ill patients
Emergency medicine |
Others
NO
To clarify whether synbiotics have beneficial effects on gut microbiota and clinical courses
Efficacy
Confirmatory
Pragmatic
Phase III
Infectious complications including enteritis, ventilator-associated pneumonia and bacteremia within 4 weeks from admission
1. Mortality within 4 weeks
2. Infectious complications including enteritis, ventilator-associated pneumonia, bacteremia within 8 weeks from admission
3. Fecal bacterial counts and organic acids
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Food |
Enteral administration of Bifidobacterium breve strain Yakult, Lactobacillus casei strain Shirota and galactooligosacchrides initiating within 72hrs after admission until initiation of oral intake
No intervention
16 | years-old | <= |
Not applicable |
Male and Female
Patients with severe sepsis treated with mechanical ventilation
Trauma patients treated with mechanical ventilation
Patients who do not receive synbiotics within 72hrs from admission
Patients who are inappropriate to perform the present trial
150
1st name | |
Middle name | |
Last name | Hiroshi Ogura |
Osaka University Graduate School of Medicine
Department of Trauma and Acute Critical Medicine
2-15 Yamadaoka, Suita City, Osaka, Japan
81-6-6879-5707
1st name | |
Middle name | |
Last name | Hiroshi Ogura |
Osaka University Graduate School of Medicine
Department of Trauma and Acute Critical Medicine
2-15 Yamadaoka, Suita City, Osaka, Japan
81-6-6879-5707
ogura@hp-emerg.med.osaka-u.ac.jp
Department of Trauma and Acute Critical Medicine, Osaka University Graduate School of Medicine
None
Self funding
Osaka General Medical Center, Osaka, Japan
Social Insurance Chukyo Hospital, Aichi, Japan
NO
大阪大学医学部附属病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、社会保険中京病院(愛知県)
Osaka University Hospital(Osaka Prefecture), Osaka General Medical Center(Osaka Prefecture), Social Insurance Chukyo Hospital(Aichi Prefecture)
2011 | Year | 09 | Month | 29 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 29 | Day |
2012 | Year | 09 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007633
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