About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Persistent albuminuria (ACR >30 and <300 mg/g).
Estimated GFR >60 mL/min/1.73 m².
No identifiable secondary cause of kidney disease.
Disqualifiers
Hypoalbuminemia.
Nephrotic syndrome.
Persistent macroalbuminuria (ACR >300 mg/g).
Secondary or hereditary kidney disease.
Trial design
Parallel
Treatments tested in this trial
symbiotic
Dietary supplement1. 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.
Placebo
Other intervention1\. 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
Treatment groups
Trial outcomes
Primary outcomes
Change in gut-derived uremic toxin levels
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum, from baseline
Primary Outcome Measure:
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum,
Sponsors and contacts
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