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Not yet recruitingNCT07808450Updated Sep 8, 2026

Nitazoxanide in Spontaneous Bacterial Peritonitis

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • SBP - Spontaneous Bacterial Peritonitis
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    Group I receiving placebo tablets

    Drug: Placebo

  • Active comparator
    Nitazoxanide group

    Drug: Nitazoxanide (NTZ)

Interventions

  • DrugNitazoxanide (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

  • DrugPlacebo

    • Group I (Control Group; N=30): Patients receiving standard SBP treatment (empirical antibiotics according to local guidelines ± albumin).

05

What researchers measure

Primary outcomes

  1. The change in polymorph nuclear cell counts (PMNCs) within 48 hours

    Time frame: 48 hours

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07808450
Lead sponsor
Tanta University
Responsible party
Khadija Ahmed Mhrose Glal (Director, Tanta University) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Sep 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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