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NOT YET RECRUITING
NCT07820046
PHASE2/PHASE3

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

Sponsor: Tanta University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2027-01-01

Completion Date

2028-01-01

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

DRUG

Nitazoxanide (NTZ)

Nitazoxanide 500 mg orally twice daily