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NCT Number: NCT07483697

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

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.

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Key information

Conditions

Exercise Behavior CKD Stage 1 CKD Stage 2 CKD Stage 3 Diet Interventions Motor Activity Symbiotic

Age range

14 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Atención Integral de Enfermedades Renales del Estado de Aguascalientes

Aguascalientes, 20180, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symbiotic

Dietary Supplement
  • Lifestyle interventions (diet + exercise)
  • Microbiota modulation with probiotics, prebiotics, and symbiotic
  • 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
  • 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

Primary outcomes

  1. Change in gut-derived uremic toxin levels

    Time frame: 180 days

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

  2. Primary Outcome Measure:

    Time frame: 180 days.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Karla Valencia V Pérez Hernández

CONTACT

[email protected]

+524491126729

Sponsors and collaborators

Lead sponsor

Centenario Hospital Miguel Hidalgo

Other

Registry information

Official study title

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

Acronym: CKD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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