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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000041744 |
Receipt No. | R000047646 |
Scientific Title | The gut microbiota of critically ill patients |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2020/09/09 |
Basic information | ||
Public title | The gut microbiota of critically ill patients | |
Acronym | The gut microbiota of critically ill patients | |
Scientific Title | The gut microbiota of critically ill patients | |
Scientific Title:Acronym | The gut microbiota of critically ill patients | |
Region |
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Condition | |||
Condition | critically ill patients | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify changes in intestinal flora |
Basic objectives2 | Others |
Basic objectives -Others | To clarify changes in intestinal flora |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Changes in intestinal flora |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients admitted to ICU | |||
Key exclusion criteria | None | |||
Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Mie University Graduate School of Medicine | ||||||
Division name | Dept of Molecular Pathobiology and Cell Adhesion Biology | ||||||
Zip code | 514-8507 | ||||||
Address | 2-174 Edobashi Tsu-City | ||||||
TEL | 059-231-5036 | ||||||
motomushimaoka@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Mie University Graduate School of Medicine | ||||||
Division name | Emergency and Disaster Medicine | ||||||
Zip code | 514-8507 | ||||||
Address | 2-174 Edobashi, Tsu 514-8507, Japan | ||||||
TEL | 0592321111 | ||||||
Homepage URL | |||||||
a_2.uk@mac.com |
Sponsor | |
Institute | Mie University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | KAKEN |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Mie University Hospital |
Address | 2-174 Edobashi, Tsu 514-8507, Japan |
Tel | 059-232-1111 |
a-2@umin.net |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | We observe changes in the intestinal microbiota obtained from the stools of patients and changes in the data related to severity and vital signs such as blood data and respiratory circulation data of patients. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047646 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |