Parasitic Infection Flares up the Activity of Ulcerative Colitis; However, Combined Immunomodulatory Therapy With Anti-parasitic Treatment Could Proceed Toward Remission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of patients reporting at least a 50% increase in the remission rate of parasitic infection (measured by changes in Serum CRP, Fecal calprotectin, and on the Simple Clinical Colitis Activity Index[SCCAI]) in patients with Ulcerative colitis.
研究概览
简要总结
The study aimed to explore the link between parasitic infections and the severity of ulcerative colitis (UC). 120 UC patients were divided into three groups: those without infection, those with Giardia lamblia infection treated with metronidazole, and those with Giardia infection treated with a combination of metronidazole and E. purpurea. The results revealed that patients with Giardia infections exhibited more severe UC symptoms. All groups experienced improved symptoms following treatment, but the combination therapy group demonstrated the most significant improvement. Remission rates were highest in the group without infection and the group receiving combination therapy. Additionally, the study identified E. purpurea therapy and a substantial reduction in SCCAI score as significant predictors of higher remission rates.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative Colitis patients had active disease,
- •Patients had parasitic infection by G. lambellia,
- •Patients free of parasitic infection,
- •Patients free of exclusion criteria..
排除标准
- •Patients had Inflammatory Bowel Disease other than Ulcerative Colitis,
- •Patients had multiple parasitic infections,
- •Patients had infection by parasites other than G. lambellia,
- •Patients who were maintained on immunosuppressant therapy,
- •Patients who were in remission and patients refused to sign the written consent to participate in the study.
研究组 & 干预措施
Control Group
干预措施: Echinacea Extract (Drug)
Group I
干预措施: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl] (Drug)
Group II
干预措施: Echinacea Extract (Drug)
Group II
干预措施: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl] (Drug)
结局指标
主要结局
Proportion of patients reporting at least a 50% increase in the remission rate of parasitic infection (measured by changes in Serum CRP, Fecal calprotectin, and on the Simple Clinical Colitis Activity Index[SCCAI]) in patients with Ulcerative colitis.
时间窗: 4 weeks
Patients had parasitic infection showed significantly higher pre-treatment SCCAI score and FCP level than patients free of infection. Post-treatment SCCAI scores of all patients were significantly lower than the pre-treatment scores.
次要结局
未报告次要终点
研究者
Heba M. Aboelela
Lecturer of Medical Parasitology
Benha University