UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050720 |
|---|---|
| Receipt number | R000057787 |
| Scientific Title | Impact of intestinal dysbiosis in acute pancreatitis: a multicenter prospective observational study |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/01/18 20:31:40 |
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Basic information
Public title
Impact of intestinal dysbiosis in acute pancreatitis
Acronym
Impact of intestinal dysbiosis in acute pancreatitis
Scientific Title
Impact of intestinal dysbiosis in acute pancreatitis: a multicenter prospective observational study
Scientific Title:Acronym
Impact of intestinal dysbiosis in acute pancreatitis: a multicenter prospective observational study
Region
| Japan |
Condition
Condition
acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the mortality rate of acute pancreatitis with high frequency of infectious complications, it is warranted to elucidate the pathophysiology and develop new treatment strategies. As it has been reported that dysbiosis, an imbalance of the intestinal microbiota in critically ill patients, contributes to poor outcomes, controlling the disruption of intestinal homeostasis could be promising tactics for infectious complications in acute pancreatitis. In this study, we aim to determine the sequential changes in intestinal microbiota using 16s RNA metagenomics and metabolomics in patients with in acute pancreatitis.
Basic objectives2
Others
Basic objectives -Others
To improve the mortality rate of acute pancreatitis with high frequency of infectious complications, it is warranted to elucidate the pathophysiology and develop new treatment strategies. As it has been reported that dysbiosis, an imbalance of the intestinal microbiota in critically ill patients, contributes to poor outcomes, controlling the disruption of intestinal homeostasis could be promising tactics for infectious complications in acute pancreatitis. In this study, we aim to determine the sequential changes in intestinal microbiota using 16s RNA metagenomics and metabolomics in patients with in acute pancreatitis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in various parameters of the intestinal microbiota, protein concentration in stool, and metabolite concentration
Key secondary outcomes
Relationship between each parameter and short- and long-term prognosis
Correlation of each parameter with treatment details and clinical course during ICU stay
Correlation between the amount of diarrhea and alpha-diversity parameters, protein concentration in each stool, and metabolite concentration
Cluster analysis in patients with acute pancreatitis
Development of artificial intelligence to predict patients' outcomes using collected clinical data and radiological information
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults (18 years of age or older)
Patients diagnosed with acute pancreatitis using the Ministry of Health, Labour and Welfare's criteria for acute pancreatitis severity
Patients newly admitted to the hospitals of the participating institution and expected to hospitalization for 48 hours or longer
Key exclusion criteria
Patients with inflammatory bowel disease
Patients with diarrhea prior to admission
Patients who have received antimicrobial agents for more than 1 week in the 2 months prior to admission
Patients who are judged to be inappropriate as research subjects by the principal investigator.
Target sample size
60
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
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN Center for Life Science Technologies, RIKEN Institute of Physical and Chemical Research.
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
千葉大学医学部附属病院、東千葉メディカルセンター、君津中央病院、慶応義塾大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.medrxiv.org/content/10.1101/2023.03.30.23287938v1
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
| 2022 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Protocol registered in medRxiv (https://www.medrxiv.org/).
Management information
Registered date
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057787
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