SBP - Spontaneous Bacterial Peritonitis
Conditions
Brief summary
Spontaneous bacterial peritonitis (SBP) is a life-threatening complication of liver cirrhosis characterized by infection of ascitic fluid in the absence of an evident intra-abdominal source. SBP occurs in approximately 10-30% of hospitalized cirrhotic patients with ascites and is associated with high short-term mortality despite advances in antimicrobial therapy. ¹˒² The pathogenesis of SBP is multifactorial and involves gut microbiota dysbiosis, increased intestinal permeability, bacterial translocation, and impaired host immune defenses. ³ Translocation of gut-derived bacteria and endotoxins, particularly lipopolysaccharides (LPS), activates systemic inflammatory pathways, promotes circulatory dysfunction, and predisposes patients to recurrent SBP episodes. ⁴˒⁵ Current management of SBP relies on empirical broad-spectrum antibiotics, most commonly third-generation cephalosporins, along with albumin infusion. ⁶ However, the increasing prevalence of multidrug-resistant organisms, recurrent SBP, and antibiotic-related adverse effects has created an urgent need for novel adjunctive or preventive strategies. ⁷ Nitazoxanide (NTZ) is a thiazolide derivative with broad-spectrum antibacterial, antiparasitic, and antiviral properties. In addition to its antimicrobial activity, NTZ has demonstrated anti-inflammatory effects, inhibition of nuclear factor-κB (NF-κB) signaling, and improved intestinal epithelial barrier integrity. ⁸˒⁹ Experimental data suggest that NTZ reduces gut permeability and systemic endotoxemia, mechanisms that are directly implicated in the development and recurrence of SBP. ¹⁰ Given the central role of bacterial translocation and systemic inflammation in SBP, Nitazoxanide may offer therapeutic benefit as an adjunct to standard antibiotic therapy. However, clinical data evaluating its efficacy and safety in SBP are limited. Therefore, this study aims to assess the role of Nitazoxanide as an adjunctive therapy in cirrhotic patients with SBP. Aim of the Study To evaluate the efficacy and safety of Nitazoxanide as an adjunctive therapy to standard treatment in patients with liver cirrhosis complicated by spontaneous bacterial peritonitis.
Interventions
• Group II (Intervention Group; N= 30): Patients receiving standard SBP treatment plus Nitazoxanide 500 mg orally twice daily for 14 days. The selected Nitazoxanide dose is based on previously published safety and pharmacological studies.¹¹˒¹²
DRUGPlacebo
• Group I (Control Group; N=30): Patients receiving standard SBP treatment (empirical antibiotics according to local guidelines ± albumin).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) with liver cirrhosis diagnosed clinically, laboratory-wise, and radiologically. * Presence of ascites. * Diagnosis of spontaneous bacterial peritonitis is defined as an ascitic fluid polymorphonuclear leukocyte count ≥250 cells/mm³, with or without positive culture. * Ability to provide written informed consent.
Exclusion criteria
* Secondary bacterial peritonitis. * Recent abdominal surgery. * Hepatocellular carcinoma or other malignancies. * Severe renal impairment (serum creatinine \>2 mg/dL). * Septic shock at presentation. * Pregnancy or lactation. * Known hypersensitivity to Nitazoxanide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in polymorph nuclear cell counts (PMNCs) within 48 hours | 48 hours |
Outcome results
None listed