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The Efficacy and Safety of Probiotic Combinations–Lobun Forte® Versus Renadyl® in Patients with Chronic Kidney Disease: A Comparative Phase IV, Randomized, Open Label, Active Controlled, Parallel Study
Background: Chronic kidney disease (CKD) often leads to gut microbiota imbalance, accelerating disease progression and increasing uremic toxins and inflammation. We conducted a randomized clinical trial comparing outcomes between two multi-strain probiotic supplements Lobun Forte® (containing Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium longum and Bacillus coagulans) and Renadyl®(containing Streptococcus thermophilus, Lactobacillus acidophilus and Bifidobacterium longum).
Materials and Methods: Sixty stage 3-4 CKD patients were randomized to receive either Lobun Forte® or Renadyl® (30 per group) for 6 months, with each supplement providing 45 billion CFU/capsule, twice daily. Primary outcomes included quality of life (SF-8 score), reductions in uremic toxins (p-cresyl sulfate [PCS], 3-indoxyl sulfate [IS], indole-3-acetic acid [IAA]), BUN, serum creatinine, and serum uric acid. Secondary outcomes assessed oxidative stress, inflammatory biomarkers, and eGFR.
Results: Both Lobun Forte® and Renadyl® groups showed significant improvements in QoL, with Lobun Forte® achieving a 53.5% improvement (16.43-point increase) and Renadyl® a 51.1% improvement (15.27-point increase) in SF-8 scores (p < 0.0001). Indoxyl sulfate (IS) levels decreased significantly in both groups (p < 0.0001), with Lobun Forte® reducing IS by 29.72% and Renadyl® by 24.20%. In terms of other uremic toxins, Lobun Forte® showed non-significant (p > 0.05) reductions in mean PCS (7.63%) and IAA (15.57%), whereas Renadyl®demonstrated a significant (p = 0.0314) decrease in PCS (20.75%) and a non-significant (p > 0.05) reduction in IAA (12.35%).
Both groups experienced significant (p < 0.0001) reductions in BUN and serum creatinine levels. Serum uric acid levels showed a significant (p = 0.0448) reduction, with Lobun Forte®, while Renadyl® exhibited a non-significant reduction (p = 0.1034).
Lobun Forte® significantly (p = 0.0359) reduced mean high-sensitivity C-reactive protein (hs-CRP) levels, while Renadyl® showed a non-significant reduction (p = 0.0876). Both groups had non-significant reductions in IL-6 and TNF-α levels (p > 0.05). Further, both groups experienced significant (p < 0.0001) increase in mean GSH levels and NO levels. Additionally, Renadyl® resulted in a significant reduction in mean malondialdehyde (MDA), whereas Lobun Forte® showed a non-significant reduction. Both probiotics significantly (p < 0.0001) improved eGFR, with Lobun Forte® increasing by 40.4% and Renadyl® by 36.9%. Both probiotics were well tolerated, with a favorable safety profile throughout the study.
Conclusion: Both Lobun Forte® and Renadyl® effectively improve the quality of life in stage 3-4 CKD patients by modulation of uremic toxins, renal parameters, inflammatory biomarkers, oxidative biomarkers and e-GFR. These findings suggest that both probiotics may help delay CKD progression by modulating the gut-kidney axis.
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