A Mechanistic Study on How Humid and Hot Environment Promotes Urinary Tract Stone Formation Through Influencing Gut Microbiota and Tryptophan Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 主要终点
- Gut microbiota differences
研究概览
简要总结
Investigating the differences in gut microbiota composition and tryptophan metabolite levels between kidney stone patients and healthy individuals, with special focus on:
- Comparing the gut microbiota composition between kidney stone patients and healthy controls, with emphasis on analyzing the relative abundance of Lactobacillus salivarius
- Comparing the differences in tryptophan metabolite levels such as indole-3-carboxylic acid (ICA) and kynurenine (Kyn) in serum between the two groups
- Exploring the correlation between gut microbiota composition and tryptophan metabolite levels
- Analyzing the influence of different environmental conditions (seasons, temperature and humidity) on gut microbiota and metabolite levels
详细描述
1. Objectives
To investigate differences in gut microbiota composition and tryptophan metabolite levels between kidney stone patients and healthy individuals, specifically focusing on:
- Comparing gut microbiota composition between stone patients and healthy controls, with emphasis on the relative abundance of Lactobacillus salivarius.
- Comparing serum levels of tryptophan metabolites-indole-3-carboxylic acid (ICA) and kynurenine (Kyn)-between groups.
- Exploring correlations between gut microbiota composition and tryptophan metabolite levels.
- Analyzing the impact of environmental conditions (season, temperature/humidity) on gut microbiota and metabolite levels.
2. Trial Design This prospective case-control study compares gut microbiota composition and serum metabolite levels between kidney stone patients (case group) and stone-free healthy volunteers (control group), while exploring associations with environmental factors.
3. Participants Case Group: Patients diagnosed with kidney stones. Control Group: Healthy volunteers without kidney stones.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for patients with kidney stones
- •Age>=18 years;
- •Diagnosed with kidney stones by ultrasound, CT or urography;
- •Willing to provide stool samples and serum samples for study;
- •No history of antimicrobial use in the past 3 months;
- •Signed and dated informed consent indicating that the patient or his/her legal representative is fully informed of the study-related information and agrees to participate.
- •Inclusion criteria for the healthy control group
- •Age>=18 years;
- •No history of kidney stones and family history;
- •Imaging examination (such as abdominal ultrasound) showed no kidney stones;
- •Willing to provide stool samples and serum samples for research;
- •No history of antibiotic use in the past 3 months;
- •Signed and dated informed consent indicating that the volunteer is fully informed about the study-related information and agrees to participate.
排除标准
- •Use of antimicrobials or probiotics within the past 3 months;
- •Presence of active urinary tract infection;
- •Presence of other serious systemic diseases, such as hepatic or renal insufficiency, cardiac or pulmonary diseases, malignant tumors, and immunodeficiency states;
- •Congenital urinary tract abnormalities;
- •Previous history of kidney transplantation or urinary diversion surgery;
- •Pregnant or lactating women;
- •Presence of chronic intestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, etc.;
- •Inability to provide samples or complete follow-up according to the research protocol;
- •Participation in other clinical studies within the past 3 months;
- •Other conditions deemed unsuitable for participation in this study by the researcher.
结局指标
主要结局
Gut microbiota differences
时间窗: 3 months postoperatively
Comparison of gut microbiota composition between the case and control groups, particularly the relative abundance of Lactobacillus salivarius. Unit of Measure: Relative abundance (unitless proportion)
Serum indole-3-carboxylic acid (ICA) concentration and Serum kynurenine (Kyn) concentration
时间窗: 3 months postoperatively
Comparison of serum ICA (indole-3-carboxylic acid) and Kyn (kynurenine) levels between the case and control groups. Unit of Measure: ng/mL.
次要结局
- Gut microbiota β-diversity(3 months postoperatively)
- Kynurenine to indole-3-carboxylic acid ratio (Kyn/ICA)(3 months postoperatively)
- Spearman correlation coefficient between Lactobacillus salivarius abundance and serum ICA concentration(3 months postoperatively)
- Gut microbiota α-diversity(3 months postoperatively)
- Relative abundance of Lactobacillus salivarius(3 months postoperatively)
- Kidney stone recurrence status(3 months postoperatively)
- Mean ambient temperature(3 months postoperatively)
- Mean ambient relative humidity(3 months postoperatively)
研究者
Yi Shao
Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine