A Phase 1/2 interventional study of Nitazoxanide (NTZ) and Placebo in SBP - Spontaneous Bacterial Peritonitis, sponsored by Tanta University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Tanta University · Phase 1/2, Interventional, and Treatment
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.
Inclusion Criteria
Drug: Placebo
Drug: Nitazoxanide (NTZ)
• 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
• Group I (Control Group; N=30): Patients receiving standard SBP treatment (empirical antibiotics according to local guidelines ± albumin).
The change in polymorph nuclear cell counts (PMNCs) within 48 hours
Time frame: 48 hours
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Tanta University