Application of Bacterial DNA Quantitative Detection in Diagnosis of SBP in Cirrhosis: A Multi Center Diagnostic Experiment

NCT06995846 | Enrolling By Invitation

• 1 other identifier: LL-2024-034-K
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cirrhosis; Ascites; Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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)

  From enrollment to the end of follow at 24 weeks

Study Arms (1)

Cirrhotic Patients with Ascites

Cirrhotic Patients with Ascites

Diagnostic Test: Bacterial DNA Levels in Ascites

Interventions

Bacterial DNA Levels in Ascites DIAGNOSTIC_TEST

The bactDNA was detected by droplet digital polymerase chain reaction (ddPCR).

Cirrhotic Patients with Ascites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cirrhotic ascites patients admitted to the liver disease departments of our hospital and various sub centers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing YouAn Hospital: lead

Study Sites (1)

No. 8 You An Men Wai Street, Fengtai District, Beijing 100069, China

Beijing, China

Location

MeSH Terms

Conditions

Fibrosis; Ascites; Bacterial Infections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate dean

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: May 30, 2025
• Study Start: April 2, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)