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

Maulik Patel; Gaurang Patel; Girish Chaudhary; Akash Dholakia

doi:10.18203/2349-3933.ijam20263721

Authors

Maulik Patel Department of Nephrology, Shankus hospital, Mehsana, Gujarat, India https://orcid.org/0009-0008-4941-3478
Gaurang Patel Department of Cardiology, Shankus hospital, Mehsana, Gujarat, India
Girish Chaudhary Department of Pulmonary Medicine, Shankus hospital, Mehsana, Gujarat, India
Akash Dholakia Department of Nephrology, Shankus hospital, Mehsana, Gujarat, India

DOI:

https://doi.org/10.18203/2349-3933.ijam20263721

Keywords:

Gut kidney axis, Hemodialysis, Inflammation, Malnutrition, Probiotics, Quality of life

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.

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