Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 2:
Nitazoxanide + Standard Therapy Nitazoxanide 500 mg orally twice daily Standard ulcerative colitis therapy Duration: 12 weeks
干预措施: Nitazoxanide (NTZ) (Drug)
Arm 1
: Placebo + Standard Therapy Standard ulcerative colitis therapy Placebo tablets twice daily fo
干预措施: Nitazoxanide (NTZ) (Drug)
结局指标
主要结局
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)
时间窗: 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.
次要结局
未报告次要终点
研究者
Khadija Ahmed Mhrose Glal
Director
Tanta University