NCT07650214尚未招募不适用
Study on the Effects and Mechanisms of Probiotic Supplementation in Ameliorating Uric Acid Metabolism in Asymptomatic Hyperuricemic Individuals
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Blood uric acid
研究概览
简要总结
This study aims to utilize a randomized controlled trial in asymptomatic hyperuricemic individuals to clarify the effects of four probiotic strains including Lactobacillus acidophilus on serum uric acid levels, pathways of uric acid synthesis, degradation and excretion, hyperuricemia-induced oxidative stress and chronic inflammatory responses, uric acid-related metabolites, gut microbiota composition and diversity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Men and women aged 18-65;
- •Residents who have lived in Guangdong for more than one year;
- •According to the "Chinese Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia-Related Diseases (2023 Edition)", asymptomatic HUA is defined as a fasting serum uric acid level >420 umol /L and no history of gout symptoms such as gouty arthritis;
- •Consent to be randomly assigned to the intervention or control group;
- •Willing to consume the probiotic products provided by the study;
排除标准
- •Secondary HUA caused by disease or drugs;
- •Within 3 months before participating in the study, or currently taking drugs that affect uric acid metabolism, such as azathioprine, thiazide diuretics, prednisone, etc., and unwilling to stop taking them during the study;
- •Taking or currently taking medication for gout within 3 months before participating in the study and unwilling to stop taking it during the study;
- •Abnormal liver function (AST or ALT levels are more than 3 times the upper limit of normal), abnormal renal function (glomerular filtration rate less than 60mL/min/1.73m^2);
- •Abnormal blood test results (such as white blood cell count < 3.5x10^9 /L, platelet count < 100x10^9 /L, hemoglobin < 90g/L) or other blood system diseases;
- •Suffering from severe cardiovascular, kidney, gastrointestinal, hepatal, and malignant tumor diseases;
- •Long-term or current use of nonsteroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and inability to stop using these drugs within 72 hours before the start of the study;
- •Currently taking anticoagulants, anabolic steroids, hydrocortisone and other hormonal drugs;
- •Use of probiotic supplements within one month prior to participating in the study, and was unwilling to discontinue taking them during the study;
- •Frequent use (more than once a day) of multivitamins, antioxidants, herbal supplements, dietary fiber-containing supplements, and other nutritional supplements (such as inulin, fish oil, soy lecithin, niacin, dietary fiber, flaxseed, phytoestrogens, sterols, etc.), or products containing prebiotics, probiotics, synbiotics, postbiotics, etc. (such as yogurt, fermented milk, beverages, or other fermented products) within 3 months prior to study participation, and unwilling to stop taking them;
- •Self-reported weight loss of more than 7 kg or 10% in the 6 months prior to enrollment;
- •Suffering from eating disorders (such as anorexia and bulimia), dysphagia, or difficulty swallowing food or medication;
- •Unable to consume the probiotic products provided by the study as required during the study period;
- •Drink more than 2 times a day, more than 14 times a week, and are unwilling to stop drinking during the study;
- •Intolerance or food allergy related to the investigational product, drug allergy, or other issues that may affect food intake;
- •Poor venous access;
- •Women who have given birth in the past year, are pregnant, or plan to become pregnant within 6 months, or are breastfeeding;
- •Participating or planning to participate in other dietary intervention studies, drug use studies, or cosmetic or pharmaceutical application studies in the next three months;
- •Participated in clinical trials in the past 3 months;
- •Any other condition that is deemed unsuitable for the trial by a physician.
研究组 & 干预措施
Placebo control
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
Probiotic intervention
Experimental
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Blood uric acid
时间窗: Weeks 0,4,8
次要结局
- Blood xanthine(Weeks 0,8)
- Blood hypoxanthine(Weeks 0,8)
- Blood xanthine oxidase(Weeks 0,8)
- Fecal uric acid(Weeks 0,8)
- Blood urea nitrogen(Weeks 0,4,8)
- Blood creatinine(Weeks 0,4,8)
- Fecal allantoin(Weeks 0,8)
- Urine uric acid(Weeks 0,8)
- Urine allantoin(Weeks 0,8)
- Serum diamine oxidase(Weeks 0,8)
- Urine oxidative stress indicator level(Weeks 0,8)
- Blood inflammatory cytokine levels(Weeks 0,8)
- Fecal gut microbiota(Weeks 0,8)
- Metabolomics(Weeks 0,8)
研究者
Huicui Meng
Associate Professor
Sun Yat-sen University
研究点 (1)
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