CirrhosisNCT06995846
Application of Bacterial DNA Quantitative Detection in Diagnosis of SBP in Cirrhosis: A Multi Center Diagnostic Experiment
An observational study of Cirrhosis and Ascites, run by Beijing YouAn Hospital at 1 site in China.
Trial summary
Background and Significance: Spontaneous bacterial peritonitis (SBP) is a common and life-threatening complication in patients with liver cirrhosis, characterized by high incidence and mortality. The current diagnostic standard relies on ascitic fluid polymorphonuclear leukocyte (PMN) count ≥250 cells/μL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Ascites, Bacterial Infections
- What is being tested?
- Bacterial DNA Levels in Ascites
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic ascites patients admitted to the liver disease departments of our hospital and various sub centers
Who may be able to join
- Age ≥ 18 years, no restriction on gender.
- Diagnosis of liver cirrhosis based on imaging, biochemical, or hematological evidence of impaired hepatic synthetic function or portal hypertension, or histologically confirmed cirrhosis, regardless of etiology.
- Diagnosis of ascites according to the 2023 Chinese Clinical Guidelines for the Diagnosis and Treatment of Cirrhotic Ascites and Related Complications.
Who cannot join
- Patients with confirmed infections in other tissues or organs.
- Ascites caused by non-hepatic etiologies, such as renal or cardiac ascites.
- Pregnant individuals, intravenous drug users, or HIV-infected individuals.
- Patients with uncontrolled hepatocellular carcinoma or other systemic malignancies.
- Patients who have previously undergone organ transplantation.
- Patients currently receiving glucocorticoids or other immunosuppressive therapies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No. 8 You An Men Wai Street, Fengtai District, Beijing 100069, China
Beijing
About this study
Background and Significance:
Spontaneous bacterial peritonitis (SBP) is a common and life-threatening complication in patients with liver cirrhosis, characterized by high incidence and mortality. The current diagnostic standard relies on ascitic fluid polymorphonuclear leukocyte (PMN) count ≥250 cells/μL. However, this threshold is associated with high rates of missed diagnoses, poor correlation with clinical symptoms, and delays in pathogen identification due to the low sensitivity and prolonged time of traditional ascitic fluid culture.
Read more
With the development of molecular diagnostics, bacterial DNA (bactDNA) detection-especially through droplet digital PCR (ddPCR)-has emerged as a promising technique due to its high sensitivity, absolute quantification capability, and robustness. This study aims to evaluate the diagnostic value and accuracy of ddPCR-based quantification of bacterial DNA in ascitic fluid for SBP, providing a novel and objective diagnostic tool to improve early and accurate detection and to inform targeted antimicrobial therapy.
Objectives:
To assess the diagnostic accuracy (sensitivity, specificity, predictive values) of ddPCR-based quantification of total bacterial DNA in ascitic fluid for SBP.
To evaluate the diagnostic performance of the ratio of Gram-positive to Gram-negative bacterial DNA (G+/G-) in predicting SBP.
To explore the potential of ddPCR-based bacterial DNA quantification as a complementary or alternative method to conventional PMN-based diagnostic criteria.
Study Design and Methods:
This is a prospective diagnostic study involving 700 patients with liver cirrhosis and ascites. Ascitic fluid samples will be analyzed using ddPCR to quantify bacterial DNA levels. These results will be compared with traditional diagnostic criteria, including PMN counts and expert panel assessments based on clinical symptoms and laboratory findings. Statistical analyses will include correlation analysis, ROC curve analysis, and consistency testing.
Expected Outcomes:
The study aims to establish the clinical efficacy of ddPCR-based quantification of bacterial DNA in ascitic fluid as a novel diagnostic marker for SBP. This method is expected to be particularly useful in atypical cases where PMN counts are <250/μL and may help guide preliminary antibiotic selection based on the proportion of Gram-positive and Gram-negative bacteria, thereby reducing empirical treatment failures and antibiotic resistance.
- Conditions
- Cirrhosis, Ascites, Bacterial Infections
- Being tested
- Bacterial DNA Levels in Ascites
- Medical subject headings
- Fibrosis, Ascites, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial DNA Levels in AscitesDiagnostic test
The bactDNA was detected by droplet digital polymerase chain reaction (ddPCR).
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic Patients with Ascites | Cirrhotic Patients with Ascites Receives: Diagnostic Test: Bacterial DNA Levels in Ascites |
What is being measured
The primary outcome is the main question the study is designed to answer.
spontaneous bacterial peritonitis (SBP)
The SBP diagnosis is based on PMN (2021 practice Guidelines on the management of ascites in cirrhosis.) a clinical composite diagnosis (2023 Chinese guidelines)
Measured: From enrollment to the end of follow at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start2 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing YouAn Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongjie Hu, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995846
- Sponsor's protocol ID
- LL-2024-034-K
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Bacterial DNA Quantitative Detection in Diagnosis of SBP in Cirrhosis: A Multi Center Diagnostic Experiment
- ClinicalTrials.gov ID
- NCT06995846
- Acronym / sponsor ID
- LL-2024-034-K
- Conditions
- Cirrhosis, Ascites, Bacterial Infections
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Beijing YouAn HospitalUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Significance:
Spontaneous bacterial peritonitis (SBP) is a common and life-threatening complication in patients with liver cirrhosis, characterized by high incidence and mortality. The current diagnostic standard relies on ascitic fluid polymorphonuclear leukocyte (PMN) count ≥250 cells/μL. However, this threshold is associated with high rates of missed diagnoses, poor correlation with clinical symptoms, and delays in pathogen identification due to the low sensitivity and prolonged time of traditional ascitic fluid culture.
With the development of molecular diagnostics, bacterial DNA (bactDNA) detection-especially through droplet digital PCR (ddPCR)-has emerged as a promising technique due to its high sensitivity, absolute quantification capability, and robustness. This study aims to evaluate the diagnostic value and accuracy of ddPCR-based quantification of bacterial DNA in ascitic fluid for SBP, providing a novel and objective diagnostic tool to improve early and accurate detection and to inform targeted antimicrobial therapy.
Objectives:
To assess the diagnostic accuracy (sensitivity, specificity, predictive values) of ddPCR-based quantification of total bacterial DNA in ascitic fluid for SBP.
To evaluate the diagnostic performance of the ratio of Gram-positive to Gram-negative bacterial DNA (G+/G-) in predicting SBP.
To explore the potential of ddPCR-based bacterial DNA quantification as a complementary or alternative method to conventional PMN-based diagnostic criteria.
Study Design and Methods:
This is a prospective diagnostic study involving 700 patients with liver cirrhosis and ascites. Ascitic fluid samples will be analyzed using ddPCR to quantify bacterial DNA levels. These results will be compared with traditional diagnostic criteria, including PMN counts and expert panel assessments based on clinical symptoms and laboratory findings. Statistical analyses will include correlation analysis, ROC curve analysis, and consistency testing.
Expected Outcomes:
The study aims to establish the clinical efficacy of ddPCR-based quantification of bacterial DNA in ascitic fluid as a novel diagnostic marker for SBP. This method is expected to be particularly useful in atypical cases where PMN counts are <250/μL and may help guide preliminary antibiotic selection based on the proportion of Gram-positive and Gram-negative bacteria, thereby reducing empirical treatment failures and antibiotic resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic Patients with Ascites | – | Diagnostic Test: Bacterial DNA Levels in AscitesCirrhotic Patients with Ascites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic ascites patients admitted to the liver disease departments of our hospital and various sub centers
Key inclusion criteria (3 listed)
- Age ≥ 18 years, no restriction on gender.
- Diagnosis of liver cirrhosis based on imaging, biochemical, or hematological evidence of impaired hepatic synthetic function or portal hypertension, or histologically confirmed cirrhosis, regardless of etiology.
- Diagnosis of ascites according to the 2023 Chinese Clinical Guidelines for the Diagnosis and Treatment of Cirrhotic Ascites and Related Complications.
Key exclusion criteria (6 listed)
- Patients with confirmed infections in other tissues or organs.
- Ascites caused by non-hepatic etiologies, such as renal or cardiac ascites.
- Pregnant individuals, intravenous drug users, or HIV-infected individuals.
- Patients with uncontrolled hepatocellular carcinoma or other systemic malignancies.
- Patients who have previously undergone organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterial DNA Levels in AscitesThe bactDNA was detected by droplet digital polymerase chain reaction (ddPCR). | Diagnostic test | Cirrhotic Patients with Ascites |
Primary outcome
spontaneous bacterial peritonitis (SBP)
Time frame: From enrollment to the end of follow at 24 weeks
The SBP diagnosis is based on PMN (2021 practice Guidelines on the management of ascites in cirrhosis.) a clinical composite diagnosis (2023 Chinese guidelines)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Ascites, run by Beijing YouAn Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spontaneous bacterial peritonitis (SBP) (time frame: From enrollment to the end of follow at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.