drugset / Trial / NCT07820046

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

NCT07820046 ↗

Phase 2/3 Not yet recruiting 44 enrolled Tanta University
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2027-01-01
Primary completion
2028-01-01
Completion
2028-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitazoxanide Other / unclassified 500 mg Oral

Indications