NCT04199325招募中不适用
Probiotics for Gout / Hyperuricemia: A Randomized, Double-blind, Intervention, Parallel Controlled, Multicenter Clinical Trial
The Affiliated Hospital of Inner Mongolia Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- serum uric acid level
研究概览
简要总结
Under the premise of double-blind and non-interference clinical treatment, to evaluate the clinical efficacy and safety of probiotic Lactobacillus Zhang combined with routine treatment for gout hyperuricemia.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for inclusion in this study only if they meet all of the following criteria
- •18-70 years old, gender unlimited ；
- •Previous history of gout ；
- •According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015；
- •fasting serum uric acid ≥ 480 μ mol / L (8mg / dl)
排除标准
- •If the subjects meet any of the following criteria, they will not be selected ：
- •Gout in the past two weeks ；
- •Secondary hyperuricemia ；
- •Patients with abnormal liver and kidney function (ALT, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the upper limit of the normal value；
- •WBC < 4.0 × 109 / L, PLT < 100 × 109 / L, HGB < 90g / L, or other hematological diseases ；
- •bad blood pressure control (BP>160mmHg/100 mmHg)
- •Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ；
- •Patients with active peptic ulcer ；
- •Patients with gastrointestinal cancer ；
- •Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ；
- •Use of drugs that affect the metabolism or excretion of uric acid and cannot / cannot be stopped, including azathioprine, 6-mercaptopterin, thiazide diuretics, aspirin (more than 325mg / day) or other salicylates ；
- •Those who need continuous prednisone treatment ；
- •Those who need antibiotic treatment for infectious diseases ；
- •Those with body mass index (BMI) greater than 30 ；
- •people with alcoholism ；
- •People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ；
- •Researchers who have received other drugs within 3 months before screening ；
- •The people who are researchers thinks it is not suitable to participate in the study.
研究组 & 干预措施
Intervention group
Experimental
干预措施: Probiotics (Dietary Supplement)
Intervention group
Experimental
干预措施: uric-acid-lowering drug (Drug)
Control group
Placebo Comparator
干预措施: uric-acid-lowering drug (Drug)
结局指标
主要结局
serum uric acid level
时间窗: 24 weeks
The serum uric acid level was standard-reaching rate at the end of 24 weeks(Percentage of patients whose serum uric acid level has decreased to less than 360umol / L )
次要结局
- Acute attack of gout(24 week)
- serum uric acid decreased from baseline(4、8、12、24 weeks)
- serum uric acid level at the 4、8、12、24 weeks(4、8、12、24 weeks)
研究者
研究点 (1)
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