About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Nitazoxanide (NTZ)
DrugNitazoxanide 500 mg orally twice daily
Treatment groups
Trial outcomes
Primary outcomes
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis). The Mayo Score ranges from 0 to 12, with higher scores indicating worse disease activity. Therefore, a decrease in score represents clinical improvement.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: