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Not yet recruiting NCT07483697

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

No phase Interventional Exercise Diet Interventions Symbiotic CKD Stage 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: symbiotic, Placebo.
Who it may be relevant to
Registry conditions: Exercise, Diet Interventions, Symbiotic, CKD Stage 1. Basic parameters: 14 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 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

Primary outcome measures

  • Change in gut-derived uremic toxin levels [Time frame: 180 days]
  • Primary Outcome Measure: [Time frame: 180 days.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Mexico · 1 center
  • Instituto de Atención Integral de Enfermedades Renales del Estado de Aguascalientes — Aguascalientes

Publications

  • Wehedy E, Shatat IF, Al Khodor S. The Human Microbiome in Chronic Kidney Disease: A Double-Edged Sword. Front Med (Lausanne). 2022 Jan 17;8:790783. doi: 10.3389/fmed.2021.790783. eCollection 2021. PMID 35111779
  • Wakino S, Hasegawa K, Tamaki M, Minato M, Inagaki T. Kidney-Gut Axis in Chronic Kidney Disease: Therapeutic Perspectives from Microbiota Modulation and Nutrition. Nutrients. 2025 Jun 9;17(12):1961. doi: 10.3390/nu17121961. PMID 40573072
  • Voroneanu L, Burlacu A, Brinza C, Covic A, Balan GG, Nistor I, Popa C, Hogas S, Covic A. Gut Microbiota in Chronic Kidney Disease: From Composition to Modulation towards Better Outcomes-A Systematic Review. J Clin Med. 2023 Mar 1;12(5):1948. doi: 10.3390/jcm12051948. PMID 36902734
  • Swanson KS, Gibson GR, Hutkins R, Reimer RA, Reid G, Verbeke K, Scott KP, Holscher HD, Azad MB, Delzenne NM, Sanders ME. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of synbiotics. Nat Rev Gastroenterol Hepatol. 2020 Nov;17(11):687-701. doi: 10.1038/s41575-020-0344-2. Epub 2020 Aug 21. PMID 32826966
  • Rysz J, Franczyk B, Lawinski J, Olszewski R, Cialkowska-Rysz A, Gluba-Brzozka A. The Impact of CKD on Uremic Toxins and Gut Microbiota. Toxins (Basel). 2021 Mar 31;13(4):252. doi: 10.3390/toxins13040252. PMID 33807343
  • Perez-Torres A, Caverni-Munoz A, Gonzalez Garcia E. Mediterranean Diet and Chronic Kidney Disease (CKD): A Practical Approach. Nutrients. 2022 Dec 25;15(1):97. doi: 10.3390/nu15010097. PMID 36615755
  • Noce A, Marchetti M, Marrone G, Di Renzo L, Di Lauro M, Di Daniele F, Albanese M, Di Daniele N, De Lorenzo A. Link between gut microbiota dysbiosis and chronic kidney disease. Eur Rev Med Pharmacol Sci. 2022 Mar;26(6):2057-2074. doi: 10.26355/eurrev_202203_28354. PMID 35363356
  • Neale EP, Rosario VD, Probst Y, Beck E, Tran TB, Lambert K. Lifestyle Interventions, Kidney Disease Progression, and Quality of Life: A Systematic Review and Meta-analysis. Kidney Med. 2023 Apr 18;5(6):100643. doi: 10.1016/j.xkme.2023.100643. eCollection 2023 Jun. PMID 37235039

Identifiers

NCT: NCT07483697 · INAER-Nutri01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗