Multimodal Intervention for Early Chronic Kidney Disease in Young People: Dysbiosis and Inflammation (CKD)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-35
SponsorCentenario Hospital Miguel Hidalgo

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • symbiotic

    Dietary supplement

    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.

  • Placebo

    Other intervention

    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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Multimodal InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
180 days
2

Primary Outcome Measure:

Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum,

Time frame
180 days.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: