A Phase 1/2 interventional study of Nitazoxanide (NTZ) and Placebo in SBP - Spontaneous Bacterial Peritonitis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 7 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: start Sep 2026 → Oct 2026, primary completion Sep 2027 → Jun 2027 and completion Sep 2027 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Nitazoxanide