Randomized Trial of Probiotic Supplementation to Slow Progression in Moderate to Severe Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating whether probiotic supplementation can slow the progression of moderate to severe chronic kidney disease CKD by improving kidney function and reducing inflammation and harmful toxins. This randomized, double-blind, placebo-controlled trial aims to assess the safety and effectiveness of probiotics in patients with CKD stages III and IV. The study also explores how probiotics affect gut microbiota composition and metabolic imbalances related to CKD. Participants will be randomly assigned to one of two groups one group will receive a daily probiotic tablet containing 10 billion CFU of Lactobacillus plantarum for 6 months, while the other group will receive a placebo tablet identical in appearance and taste. After the 6-month treatment period, both groups will be followed for an additional 6 months without treatment to observe any lasting effects. The study involves regular clinical visits and laboratory tests to monitor treatment impact. During the study, participants will attend clinic visits at baseline, 6 months, and 12 months for checkups including blood and urine tests to measure kidney function, inflammation markers, and gut-derived toxins. Researchers will track changes in serum creatinine, estimated glomerular filtration rate eGFR, urinary protein, and systemic inflammation markers like C-reactive protein and ferritin. Safety and tolerability of the probiotic supplementation will also be assessed throughout the trial, which lasts a total of 12 months per participant.

Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial