Nitazoxanide Added to Usual Care for Mild-to-Moderate Ulcerative Colitis
Tests nitazoxanide alongside standard care versus placebo in adults with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis
Key facts
- Where
- Tanta, EgyptSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07820046, who can take part
Where in Egypt
- Tanta University HospitalTanta, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tanta University
- Trial code
- NCT07820046
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Inclusion: 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.