Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial

Summary

The goal of this clinical trial is to learn whether probiotic supplementation can slow disease progression in patients with moderate to severe chronic kidney disease (CKD). The trial will also assess the safety of probiotics in these patients. The main questions the study aims to answer are: Does probiotic supplementation improve kidney function by reducing serum creatinine levels and protein in urine? Does it reduce inflammation and metabolic imbalances in CKD patients? Does it affect gut microbiota composition and lower harmful toxins in the body? Is probiotic supplementation safe and well-tolerated in CKD patients? Participants will: Be randomly assigned to receive either probiotics or a placebo for 6 months. Have clinic visits every 6 months for checkups, blood tests, and urine tests. Be monitored for any side effects and changes in kidney function. Researchers will compare the probiotic group to the placebo group to determine whether probiotics are effective in slowing CKD progression.

Timeline

Start

2025-04-03

Primary completion

2025-10-03

Completion

2025-10-20

Publications

• Background Seth A, Yan F, Polk DB, Rao RK. Probiotics ameliorate the hydrogen peroxide-induced epithelial barrier disruption by a PKC- and MAP kinase-dependent mechanism. Am J Physiol Gastrointest Liver Physiol. 2008 Apr;294(4):G1060-9. doi: 10.1152/ajpgi.00202.2007. Epub 2008 Feb 21.
• Background de Araujo EMR, Meneses GC, Carioca AAF, Martins AMC, Daher EF, Silva Junior GB. Use of probiotics in patients with chronic kidney disease on hemodialysis: a randomized clinical trial. J Bras Nefrol. 2023 Apr-Jun;45(2):152-161. doi: 10.1590/2175-8239-JBN-2022-0021en.
• Background Miranda Alatriste PV, Urbina Arronte R, Gomez Espinosa CO, Espinosa Cuevas Mde L. Effect of probiotics on human blood urea levels in patients with chronic renal failure. Nutr Hosp. 2014 Mar 1;29(3):582-90. doi: 10.3305/nh.2014.29.3.7179.
• Background Tian N, Li L, Ng JK, Li PK. The Potential Benefits and Controversies of Probiotics Use in Patients at Different Stages of Chronic Kidney Disease. Nutrients. 2022 Sep 29;14(19):4044. doi: 10.3390/nu14194044.

Drugs

Indications