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
- Diseases
- Ulcerative colitis
- 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
This page is information, not medical advice. Discuss any trial with your doctor.