SBP - Spontaneous Bacterial PeritonitisPhase 1/2NCT07808450
Nitazoxanide in Spontaneous Bacterial Peritonitis
A Phase 1/2 study testing Nitazoxanide (NTZ) in people with SBP - Spontaneous Bacterial Peritonitis, run by Tanta University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SBP - Spontaneous Bacterial Peritonitis
- What is being tested?
- Nitazoxanide (NTZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Hepatocellular carcinoma or other malignancies.
- Severe renal impairment (serum creatinine >2 mg/dL).
- Septic shock at presentation.
- Pregnancy or lactation.
- Known hypersensitivity to Nitazoxanide
Who cannot join
None listed.
About this study
Official title: Evaluation of Nitazoxanide as Adjunctive Therapy for Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis: A Randomized Controlled Clinical Trial Protocol
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.
- Conditions
- SBP - Spontaneous Bacterial Peritonitis
- Being tested
- Nitazoxanide (NTZ), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitazoxanide (NTZ)Drug
- 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
PlaceboDrug
- Group I (Control Group; N=30): Patients receiving standard SBP treatment (empirical antibiotics according to local guidelines ± albumin).
| Study group | Role | What they receive |
|---|---|---|
| Group I receiving placebo tablets | Placebo comparator | Not described Receives: Drug: Placebo |
| Nitazoxanide group | Active comparator | Not described Receives: Drug: Nitazoxanide (NTZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in polymorph nuclear cell counts (PMNCs) within 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SBP - Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Ahmed Mhrose Glal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808450
- Sponsor's protocol ID
- Nitazoxanide in SBP
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nitazoxanide as Adjunctive Therapy for Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis: A Randomized Controlled Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT07808450
- Acronym / sponsor ID
- Nitazoxanide in SBP
- Conditions
- SBP - Spontaneous Bacterial Peritonitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I receiving placebo tablets | Placebo comparator | Drug: Placebo |
| Nitazoxanide group | Active comparator | Drug: Nitazoxanide (NTZ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Nitazoxanide group |
| Placebo• Group I (Control Group; N=30): Patients receiving standard SBP treatment (empirical antibiotics according to local guidelines ± albumin). | Drug | Group I receiving placebo tablets |
Primary outcome
The change in polymorph nuclear cell counts (PMNCs) within 48 hours
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes
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Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitazoxanide (NTZ) in people with SBP - Spontaneous Bacterial Peritonitis, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in polymorph nuclear cell counts (PMNCs) within 48 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.