CKD Stage 1, CKD Stage 2, CKD Stage 3, Diet Interventions, Exercise, Symbiotic
Conditions
Keywords
CKD, exercise, symbiotic, diet
Brief summary
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.
Detailed description
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.
Interventions
1. Lifestyle interventions (diet + exercise) 2. Microbiota modulation with probiotics, prebiotics, and symbiotic 3. It will be quantified using IL-1β, IL-6 and TNF-α for their role in the chronic inflammatory response associated with dysbiosis and accumulation of intestinal uremic metabolites described in CKD.
1\. Lifestyle interventions (diet + exercise) 2. Their role in the chronic inflammatory response associated with dysbiosis and accumulation of intestinal uremic metabolites described in CKD will be quantified using IL-1β, IL-6 and TNF-α. 3. placebo
Sponsors
Study design
Masking description
Single-blind (Participant)
Intervention model description
Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Participant) Primary Purpose: Prevention Duration: 180 days
Eligibility
Inclusion criteria
* Persistent albuminuria (ACR \>30 and \<300 mg/g). * Estimated GFR \>60 mL/min/1.73 m². * No identifiable secondary cause of kidney disease.
Exclusion criteria
* Hypoalbuminemia. * Nephrotic syndrome. * Persistent macroalbuminuria (ACR \>300 mg/g). * Secondary or hereditary kidney disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gut-derived uremic toxin levels | 180 days | Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum, from baseline |
| Primary Outcome Measure: | 180 days. | Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum, |
Countries
Mexico
Contacts
Centenario Hospital Miguel Hidalgo