Effects of multistrain probiotic supplementation on systemic inflammation, nutritional status, functional capacity and quality of life in maintenance hemodialysis: an open-label randomized controlled trial

Abstract

Background: Persistent inflammation, protein-energy wasting, impaired physical function and reduced health-related quality of life are common among patients receiving maintenance hemodialysis. Intestinal dysbiosis and increased exposure to gut-derived inflammatory mediators may contribute to these abnormalities. This study evaluated the effects of multistrain probiotic supplementation on inflammatory, nutritional, functional, clinical, safety and patient-reported outcomes in adults undergoing maintenance hemodialysis. Methods: This prospective, single-center, open-label, parallel-group randomized controlled trial enrolled 60 adults receiving maintenance hemodialysis. Participants were randomized in a 1:1 ratio to receive a daily four-strain probiotic plus standard hemodialysis care or standard care alone for 6 months. The primary outcome was the systemic immune-inflammation index (SII) at month 6. Secondary outcomes included the neutrophil-to-lymphocyte ratio (NLR), C-reactive protein (CRP), red cell distribution width (RDW), serum albumin, malnutrition-inflammation score (MIS), handgrip strength, kidney disease quality of life-36 (KDQOL-36), hospitalization, adherence, nutritional response, all-cause mortality and adverse events. Results: At month 6, the probiotic group had significantly lower SII (p=0.013), NLR (p=0.024), CRP (p=0.045), RDW (P=0.010) and MIS (p=0.018) and significantly higher serum albumin (p=0.005), handgrip strength (p=0.027) and KDQOL-36 scores (p=0.031) than the control group. No statistically significant between-group differences were observed in hospitalization, adherence, predefined nutritional response, all-cause mortality, gastrointestinal adverse events or serious intervention-related adverse events. Conclusions: Six months of multistrain probiotic supplementation was associated with favorable changes in systemic inflammation, nutritional status, muscle strength and kidney disease-specific quality of life among adults receiving maintenance hemodialysis. No detectable benefit was observed for hospitalization, mortality or adverse-event frequency. These findings should be interpreted cautiously because of the modest sample size and open-label, single-center design.