Multimodal Intervention and Its Association With Reduced Dysbiosis and Inflammation in Early Chronic Kidney Disease in Young People: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in gut-derived uremic toxin levels
研究概览
简要总结
Chronic kidney disease (CKD) is a progressive condition associated with substantial morbidity, mortality, and healthcare costs. Early detection and timely intervention are critical to modify disease trajectory, particularly in adolescents and young adults. Emerging evidence supports the role of the gut-kidney axis in CKD progression, whereby intestinal dysbiosis contributes to systemic inflammation and accumulation of microbiota-derived uremic toxins. This randomized controlled clinical trial aims to evaluate whether a multimodal intervention consisting of a controlled diet, structured exercise, and a symbiotic administered for 180 days improves uremic toxin burden, systemic inflammation, and early renal outcomes compared with standard care plus placebo.
详细描述
This is a prospective, randomized, controlled clinical trial with repeated measurements and longitudinal follow-up. Participants aged 14-35 years with early-stage CKD, defined by persistent albuminuria despite preserved glomerular filtration, will be recruited through an institutional renal screening program in Aguascalientes, Mexico. The intervention targets the gut-kidney axis through sustained lifestyle modification and microbiota modulation. The primary mechanistic hypothesis is that reducing intestinal dysbiosis will decrease microbiota-derived uremic toxins and systemic inflammation, potentially attenuating early markers of renal disease progression.
Written informed consent will be obtained from participants aged 18 years or older. For participants under 18 years of age, written assent will be obtained along with informed consent from a parent or legal guardian.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Single-blind (Participant)
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent albuminuria (ACR >30 and <300 mg/g).
- •Estimated GFR >60 mL/min/1.73 m².
- •No identifiable secondary cause of kidney disease.
排除标准
- •Hypoalbuminemia.
- •Nephrotic syndrome.
- •Persistent macroalbuminuria (ACR >300 mg/g).
- •Secondary or hereditary kidney disease.
研究组 & 干预措施
Multimodal Intervention
Participants will receive a controlled diet, a structured exercise program, and an oral symbiotic supplement administered once daily at a fixed dose for 180 days.
干预措施: symbiotic (Dietary Supplement)
Control
Participants will receive the same controlled diet and structured exercise program plus an oral placebo indistinguishable from the symbiotic, administered once daily for 180 days.
干预措施: Placebo (Other)
结局指标
主要结局
Change in gut-derived uremic toxin levels
时间窗: 180 days
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum, from baseline
Primary Outcome Measure:
时间窗: 180 days.
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum,
次要结局
未报告次要终点
研究者
Karla Valencia Perez Hernandez
Nutritionist
Centenario Hospital Miguel Hidalgo