UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048779 |
|---|---|
| Receipt number | R000055576 |
| Scientific Title | Pathophysiological analysis of disruption of intestinal homeostasis and diarrhea in critically ill patients |
| Date of disclosure of the study information | 2022/08/29 |
| Last modified on | 2022/08/29 18:22:21 |
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Basic information
Public title
Pathophysiological analysis of diarrhea in critically ill patients
Acronym
Pathophysiological analysis of diarrhea in critically ill patients
Scientific Title
Pathophysiological analysis of disruption of intestinal homeostasis and diarrhea in critically ill patients
Scientific Title:Acronym
Pathophysiological analysis of disruption of intestinal homeostasis and diarrhea in critically ill patients
Region
| Japan |
Condition
Condition
critically ill patients
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the pathogenesis of diarrhea by identifying changes in the intestinal microbiota and the dynamics of intestinal epithelial cells, immunity and metabolism in critically ill patients presenting with diarrhea.
Basic objectives2
Others
Basic objectives -Others
While diarrhea frequently occurs in critically ill patients and is associated with poor outcome, it is difficult to identify the cause in many cases. Although intestinal dysbiosis, impaired barrier function, and immune and metabolic abnormalities occur in severe disease, the relationship between disruption of intestinal homeostasis and diarrhea has not been elucidated. The aim of this study is to elucidate the pathogenesis of diarrhea by identifying changes in intestinal microbiota and the dynamics of intestinal epithelial cells, immunity, and metabolism in critically ill patients with diarrhea.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in dysbiosis of intestinal microbiota, stool protein concentration, and metabolite concentration in patients with diarrhea.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients expected to require intensive care for more than 48 hours
Key exclusion criteria
Patients with inflammatory bowel disease
Patients with diarrhea prior to ICU admission
Patients who have received multiple antimicrobial agents for a long period of time prior to ICU admission
Patients who are judged by the principal investigator to be inappropriate as study subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taka-aki |
| Middle name | |
| Last name | Nakada |
Organization
Chiba University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
TEL
4042227171
taka.nakada@nifty.com
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Oami |
Organization
Chiba University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
TEL
4042227171
Homepage URL
seveneleven711thanks39@msn.com
Sponsor or person
Institute
Chiba University Hospital
Emergency and Critical Care Medicine
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
Emergency and Critical Care Medicine
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
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
Chiba University Hospital
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
Tel
4042227171
prc-jim@chiba-u.jp
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
| 2022 | Year | 08 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adverse events will not occur due to the observational nature of the study.
Management information
Registered date
| 2022 | Year | 08 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055576
