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NCT07820046Not yet recruitingPhase 2/3

Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis

Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance. Emerging evidence suggests that intestinal barrier dysfunction, microbiota dysbiosis, and immune dysregulation play central roles in UC pathogenesis. Nitazoxanide is a broad-spectrum antiparasitic agent with demonstrated antimicrobial, anti-inflammatory, and immunomodulatory effects, including inhibition of NF-κB signaling and improvement of intestinal barrier integrity. Preclinical studies suggest potential benefit in experimental colitis models; however, clinical evidence remains limited. This randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of nitazoxanide as an adjunct to standard therapy in patients with mild-to-moderate ulcerative colitis over a 12-week treatment period.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
44 (estimated)
First submitted
3 Sept 2026
Start date
1 Jan 2027
Primary completion date
1 Jan 2028
Lead sponsor
Tanta University
NCT number
NCT07820046

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 44
  • From 1 Jan 2027 to the primary completion date, 1 Jan 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Age 18-65 years
  • Confirmed ulcerative colitis ≥ 6 months
  • Mild-to-moderate active disease (Mayo score 3-10)
  • Stable UC therapy ≥ 8 weeks before enrollment Exclusion Criteria
  • Severe/fulminant UC requiring hospitalization or surgery
  • Active intestinal infection (e.g., C. difficile)
  • Antibiotics/probiotics/investigational drugs within 4 weeks
  • Recent biologic initiation or dose change
  • Severe hepatic, renal, cardiovascular disease, or malignancy
  • Pregnancy or lactation
  • Known hypersensitivity to nitazoxanide

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.