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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07483697
Acronym
CKD
Enrollment
200
Registered
2026-03-19
Start date
2026-04-25
Completion date
2026-11-03
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

DIETARY_SUPPLEMENTsymbiotic

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.

OTHERPlacebo

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

Centenario Hospital Miguel Hidalgo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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

Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Change in gut-derived uremic toxin levels180 daysChange 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

CONTACTKarla Valencia V Pérez Hernández
valencia.iaier@gmail.com+524491126729
PRINCIPAL_INVESTIGATORKarla Valencia V Pérez Hernández, nutritionist

Centenario Hospital Miguel Hidalgo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026