A Single Center, Randomized Controlled Clinical Study on the Effect of L-ornithine on the Efficacy of Ustekinumab in Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Endoscopic remission rate
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of supplementing L-ornithine compared to the control group on the efficacy of Ustekinumab in patients with Crohn's disease, and to summarize the role of supplementing L-ornithine in the treatment of CD patients.
Participants will be randomized into two groups: the L-ornithine supplementation group and the control group. The patients in the L-ornithine supplementation group received oral ornithine capsules for 8 weeks. The control group did not receive additional intervention. Follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.
详细描述
The goal of this clinical trial is to evaluate the effect of supplementing L-ornithine compared to the control group on the efficacy of Ustekinumab in patients with Crohn's disease, and to summarize the role of supplementing L-ornithine in the treatment of CD patients.
Participants will be randomized into two groups: the L-ornithine supplementation group and the control group. Patients in the L-ornithine supplementation group take oral ornithine capsules twice a day, three capsules per time, for 8 weeks, each containing 500mg of L-ornithine. The control group did not receive additional intervention. Follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, ≤ 75 years old;
- •Patients clinically diagnosed with Crohn's disease shall refer to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) for diagnostic criteria;
- •Patients receiving treatment with Ustekinumab;
- •Agree to participate in this study and sign an informed consent form.
排除标准
- •Participants who meet any of the following criteria are not eligible for inclusion in this study.
- •Patients with ALT or AST exceeding the normal upper limit by more than twice, and TBIL exceeding the normal upper limit by more than twice;
- •Patients with creatinine clearance rate less than 60ml/min;
- •Patients with severe active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs;
- •Patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors;
- •Pregnant and lactating women;
- •The fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/L or glycosylated hemoglobin exceeds 6.5%;
- •Merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study;
- •Have participated in any other clinical research within the first month prior to enrollment;
- •The researcher determined that any other disease or condition is not suitable for patients participating in this study.
结局指标
主要结局
Endoscopic remission rate
时间窗: 8 weeks
Endoscopic remission is defined using the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score ranges from 0 to 60, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Endoscopic remission was defined as an SES-CD score ≤2.
Clinical remission rate
时间窗: 8 weeks
Clinical remission is defined using the Crohn's Disease Activity Index (CDAI). The CDAI score ranges from 0 to approximately 600, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Clinical remission was defined as a CDAI score ≤150.
次要结局
- Biomarker target attainment rate(8 weeks)