UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062412 |
|---|---|
| Receipt number | R000071286 |
| Scientific Title | Effect of Prophylactic Antibiotics for Cirrhosis with Ascites: Systematic Review and Network Meta Analysis |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/30 16:01:06 |
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Basic information
Public title
A systematic review of the effectiveness of prophylactic antibiotics for patients with cirrhosis and ascites
Acronym
Cirrhosis-Ascites Antibiotic SR
Scientific Title
Effect of Prophylactic Antibiotics for Cirrhosis with Ascites: Systematic Review and Network Meta Analysis
Scientific Title:Acronym
CAPA-SR
Region
| Japan |
Condition
Condition
Cirrhosis with Ascites
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to systematically evaluate the efficacy of prophylactic antibiotics for preventing spontaneous bacterial peritonitis (SBP) in patients with cirrhosis with ascites, assess their impact on survival, and compare the relative effectiveness of individual prophylactic antibiotic regimens using a systematic review and network meta-analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of spontaneous bacterial peritonitis (SBP)
Key secondary outcomes
All-cause mortality
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Randomized controlled trials enrolling adults with cirrhosis and ascites that compared any prophylactic antibiotic regimen with placebo or no prophylactic antibiotics and reported at least one prespecified outcome of interest (prevention of SBP / all-cause mortality).
Key exclusion criteria
Studies meeting any of the following criteria will be excluded:
Studies including patients with active spontaneous bacterial peritonitis (SBP) at enrollment
Studies in which antibiotics were administered for the treatment of infections other than SBP prophylaxis
Studies from which data on SBP incidence, all-cause mortality, or other prespecified outcomes could not be extracted
Duplicate reports with overlapping study populations or data
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Sakai |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
The Clinical Translational Research
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5308
kyosakai@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Sakai |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
The Clinical Translational Research
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5308
Homepage URL
kyosakai@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2026 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071286
