NCT07483697

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

Multimodal Intervention and Its Association With Reduced Dysbiosis and Inflammation in Early Chronic Kidney Disease in Young People: a Prospective Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Centenario Hospital Miguel Hidalgo · Academic / Other
• Sex: All
• Age: 14 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exercise
• Diet Interventions
• Symbiotic
• CKD Stage 1
• CKD Stage 3
• CKD Stage 2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	symbiotic	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.
OTHER	Placebo	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

Timeline

• Start date: 2026-04-25
• Primary completion: 2026-08-01
• Completion: 2026-11-03
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Mexico