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

NCT07483697 | Not Yet Recruiting DMC

• 1 other identifier: INAER-Nutri01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

CKD; exercise; symbiotic; diet

Outcome Measures

Primary Outcomes (2)

• 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

  180 days

• Primary Outcome Measure:

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

  180 days.

Study Arms (2)

Multimodal Intervention

EXPERIMENTAL

Participants will receive a controlled diet, a structured exercise program, and an oral symbiotic supplement administered once daily at a fixed dose for 180 days.

Dietary Supplement: symbiotic

Control

PLACEBO COMPARATOR

Participants will receive the same controlled diet and structured exercise program plus an oral placebo indistinguishable from the symbiotic, administered once daily for 180 days.

Other: Placebo

Interventions

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.

Multimodal Intervention

Placebo OTHER

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

Control

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Persistent albuminuria (ACR \>30 and \<300 mg/g).
• Estimated GFR \>60 mL/min/1.73 m².
• No identifiable secondary cause of kidney disease.

You may not qualify if:

• Hypoalbuminemia.
• Nephrotic syndrome.
• Persistent macroalbuminuria (ACR \>300 mg/g).
• Secondary or hereditary kidney disease.

Sponsors & Collaborators

• Centenario Hospital Miguel Hidalgo: lead

Study Sites (1)

Instituto de Atención Integral de Enfermedades Renales del Estado de Aguascalientes

Aguascalientes, Aguascalientes, 20180, Mexico

Location

Related Publications (20)

• 22. Wehedy, E., Shatat, I. F., & Al Khodor, S. (2022). The human microbiome in chronic kidney disease: A double-edged sword. Frontiers in Medicine, 8, 790783. https://doi.org/10.3389/fmed.2021.790783

  BACKGROUND

• 21. Wakino, S., Hasegawa, K., Tamaki, M., Minato, M., & Inagaki, T. (2025). Kidney-gut axis in chronic kidney disease: Therapeutic perspectives from microbiota modulation and nutrition. Nutrients, 17(12), 1961. https://doi.org/10.3390/nu17121961

  BACKGROUND

• 20. Voroneanu, L., Burlacu, A., Brinza, C., Covic, A., Balan, G. G., Nistor, I., Popa, C., Hogas, S., & Covic, A. (2023). Gut microbiota in chronic kidney disease: From composition to modulation towards better outcomes-A systematic review. Journal of Clinical Medicine, 12(5), 1948. https://doi.org/10.3390/jcm12051948

  BACKGROUND

• 19. Swanson, K. S., Gibson, G. R., Hutkins, R., Reimer, R. A., Reid, G., Verbeke, K., Scott, K. P., Holscher, H. D., Azad, M. B., Delzenne, N. M., & Sanders, M. E. (2020). The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of synbiotics. Nature Reviews Gastroenterology & Hepatology, 17(11), 687-701. https://doi.org/10.1038/s41575-020-0344-2

  BACKGROUND

• 18. Rysz, J., Franczyk, B., Ławiński, J., & Gluba-Brzózka, A. (2021). The impact of CKD on uremic toxins and gut microbiota. Toxins, 13(4), 252. https://doi.org/10.3390/toxins13040252

  BACKGROUND

• 16. Obrero, T. (2025). Probiotic supplementation in chronic kidney disease: Current evidence and future directions. Toxins, 18(1), 6. https://doi.org/10.3390/toxins18010006 17. Pérez-Torres, A., Caverni-Muñoz, A., & González García, E. (2022). Mediterranean diet and chronic kidney disease (CKD): A practical approach. Nutrients, 15(1), 97. https://doi.org/10.3390/nu15010097

  BACKGROUND

• 15. Noce, A., Marrone, G., Wilson Jones, G., Di Lauro, M., Pietroboni Zaitseva, A., Ramadori, L., Celotto, R., Mitterhofer, A. P., & Di Daniele, N. (2022). Link between gut microbiota dysbiosis and chronic kidney disease. European Review for Medical and Pharmacological Sciences, 26(6), 2057-2074. https://doi.org/10.26355/eurrev_202203_28354

  BACKGROUND

• 14. Neale, E. P., Rosario, V. D., Probst, Y., Beck, E., Tran, T. B., & Lambert, K. (2023). Lifestyle interventions, kidney disease progression, and quality of life: A systematic review and meta-analysis. Kidney Medicine, 5(6), 100643. https://doi.org/10.1016/j.xkme.2023.100643

  BACKGROUND

• 13. Mitrović, M., Stanković-Popović, V., Tolinački, M., Golić, N., Soković Bajić, S., Veljović, K., Nastasijević, B., Soldatović, I., Svorcan, P., & Dimković, N. (2023). The impact of synbiotic treatment on the levels of gut-derived uremic toxins, inflammation, and gut microbiome of chronic kidney disease patients: A randomized trial. Journal of Renal Nutrition, 33(2), 278-288. https://doi.org/10.1053/j.jrn.2022.07.008

  BACKGROUND

• 12. Liu, C., Wang, Y., Lin, J., et al. (2022). Effects of microbiota-driven therapy on circulating indoxyl sulfate and p-cresyl sulfate in chronic kidney disease: A systematic review. Toxins, 14(3), 189.

  BACKGROUND

• 11. Liu, C., Yang, L., Wei, W., & Fu, P. (2024). Efficacy of probiotics/synbiotics supplementation in patients with chronic kidney disease: A systematic review and meta-analysis of randomized controlled trials. Frontiers in Nutrition, 11, 1434613. https://doi.org/10.3389/fnut.2024.1434613

  BACKGROUND

• 10. Levin, A., Stevens, P. E., Bilous, R. W., et al. (2024). Executive summary of the KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney International, 105(4), 684-701.

  BACKGROUND

• 9. Kwon, Y.-J., Joo, Y. S., Yun, H.-R., Lim, L. R., Yang, J., Lee, H. S., Kim, H.-M., Lee, H., Lee, J. E., & Lee, J.-W. (2024). Safety and impact of the Mediterranean diet in patients with chronic kidney disease: A pilot randomized crossover trial. Frontiers in Nutrition, 11, 1463502. https://doi.org/10.3389/fnut.2024.1463502

  BACKGROUND

• 8. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. (2024). KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney International, 105(4S), S117-S314. https://doi.org/10.1016/j.kint.2023.10.018

  BACKGROUND

• 6. Holle, J., & Bartolomaeus, H. (2025). Gut-derived metabolites as treatment targets in chronic kidney disease-an avenue toward personalized medicine. Pediatric Nephrology, 40(5), 1505-1510. https://doi.org/10.1007/s00467-024-06609-w

  BACKGROUND

• 5. Duan, S., Pi, J., Wang, C.-H., et al. (2022). Assessment of ELISA-based method for the routine examination of serum indoxyl sulfate in patients with chronic kidney disease. Heliyon, 8(12), e12220. https://doi.org/10.1016/j.heliyon.2022.e12220

  BACKGROUND

• 4. Chen, C., Zeng, Y., Zhu, J., et al. (2023). Probiotics, prebiotics, and synbiotics for patients on dialysis: A meta-analysis. Seminars in Dialysis, 36(1), 14-26. https://doi.org/10.1111/sdi.13139

  BACKGROUND

• 3. Cedillo-Flores, R., et al. (2025). Impact of gut microbiome modulation on uremic toxin reduction in CKD: A systematic review and network meta-analysis. Kidney Medicine, 7(1), 100926. https://doi.org/10.1016/j.xkme.2024.100926

  BACKGROUND

• 2. Battaglia, Y., Baciga, F., Bulighin, F., Amicone, M., Mosconi, G., Storari, A., Brugnano, R., Pozzato, M., Motta, D., D'Alessandro, C., Torino, C., Mallamaci, F., Cupisti, A., Aucella, F., Capitanini, A., & Working Group of Physical Exercise of Italian Society of Nephrology. (2024). Physical activity and exercise in chronic kidney disease: Consensus statements from the Physical Exercise Working Group of the Italian Society of Nephrology. Journal of Nephrology, 37(7), 1735-1765. https://doi.org/10.1007/s40620-024-02049-9

  BACKGROUND

• 1. Alobaidi, S. (2025). The gut-kidney axis in chronic kidney disease: Mechanisms, microbial metabolites, and microbiome-targeted therapeutics. Frontiers in Medicine, 12, 1675458. https://doi.org/10.3389/fmed.2025.1675458

  BACKGROUND

Related Links

• Registro Estatal Único de Enfermedad Renal Crónica del Estado de Aguascalientes: Prevalencia.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Karla Valencia V Pérez Hernández, nutritionist

  Centenario Hospital Miguel Hidalgo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karla Valencia V Pérez Hernández

CONTACT

+524491126729; valencia.iaier@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blind (Participant)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Model Details: Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Participant) Primary Purpose: Prevention Duration: 180 days

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 19, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 3, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

ME (1)