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NCT Number: NCT07820046

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.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitazoxanide (NTZ)

Drug

Nitazoxanide 500 mg orally twice daily

Primary outcomes

  1. Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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