Randomized Controlled Trial of Strain-Specific Probiotic Formulation (Renadyl) in Dialysis Patients

Abstract

Background. Primary goal of this randomized, double-blind, placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins. Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress. Methods. Two 2-month treatment periods separated by 2-month washout and crossover, with physical examinations, venous blood testing, and quality of life questionnaires completed at each visit. Data were analyzed with SAS V9.2. Results. 22 subjects (79%) completed the study. Observed trends were as follows (none reaching statistical significance): decline in WBC count (−0.51 × 109/L, P = 0.057) and reductions in levels of C-reactive protein (−8.61 mg/L, P = 0.071) and total indoxyl glucuronide (−0.11 mg%, P = 0.058). No statistically significant changes were observed in other uremic toxin levels or measures of QOL. Conclusions. Renadyl appeared to be safe to administer to ESRD patients on hemodialysis. Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease. Efficacy could not be confirmed definitively, primarily due to small sample size and low statistical power—further studies are warranted.

A prospective study to evaluate the safety and efficacy of symbiotic supplementation (probiotic and prebiotic combination) in stage 5D chronic kidney disease patients

“…They observed a tendency for a decrease in Creactive protein in 22 MHD patients after 8 weeks of probiotics supplementation. 23 In our study 34.21% and 28.94% of patients had a significant decrease in BUN and urea levels from baseline. Decrease in creatinine levels of 28.9% of patient was not significant probably as they were in End Stage Renal Disease (ESRD).…”

Update on Inflammation in Chronic Kidney Disease

“…It was suggested that uremic toxins may contribute to intestinal dysbiosis in CKD and lead to an increased translocation of gut bacteria and bacterial components into the circulation, which can in turn activate systemic inflammation [49,50,51]. A recent cross-sectional study in stage 3-4 CKD demonstrated that indoxyl sulfate and p-cresyl sulfate (nephro- and cardiovascular toxins, produced solely by the gut microbiota) were associated with elevated levels of inflammatory biomarkers as well as with increased arterial stiffness [52].…”

Altered microbiome in chronic kidney disease: systemic effects of gut-derived uremic toxins

“…A pilot multinational trial in patients with CKD stages 3 and 4 noted significant decrease in blood urea levels and improved quality of life scores after treatment with the Renadyl formulation of Streptococcus thermophilus, Lactobacillus acidophilus, and Bifidobacterium longum over 6 months [130]. However, the follow-up randomized controlled trial (which had only 22 patients) failed to reduce plasma concentrations of uremic toxins and did not improve quality of life parameters [131]. The lack of benefit with probiotics may be explained by persistent uremia-induced changes in the gut biochemical environment and dietary and medicinal regimens which create an unfavorable milieu for the symbiotic microbiota [34].…”