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

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 Criteria * 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