Clinical Trial

Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients

Study acronym: ProSyn-HD
Not Yet Recruiting
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Record status
This record was last updated March 24, 2025 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to investigate the impact of probiotics and synbiotics on the nutritional status of patients with end-stage kidney disease (ESRD) who are undergoing hemodialysis. ESRD patients often face challenges such as poor nutritional status, increased risk of infections, and imbalances in gut microbiota. These challenges are made worse by the frequent use of medications, dietary restrictions, and the hemodialysis process itself, which can disturb the gut's natural bacteria balance. Probiotics are live microorganisms that provide health benefits when taken in adequate amounts, while synbiotics are a combination of probiotics and prebiotics (substances that promote the growth of beneficial bacteria). The goal of this study is to explore whether supplementing ESRD patients with probiotics or synbiotics can improve their nutritional health, including aspects like body mass index (BMI), skin fold thickness, and protein metabolism. The study will involve 60 patients from a hemodialysis center in Mansoura, Egypt. Patients will be randomly assigned to one of three groups: one group will receive probiotics, another will receive synbiotics, and the third group will act as a control (no treatment). The study will evaluate changes in nutritional markers and other health parameters before and after six months of supplementation. This study hopes to provide insights into new, cost-effective interventions for improving the health of patients undergoing long-term dialysis treatment by addressing the question of whether these supplements can improve the nutritional status of hemodialysis patients.
Trial Details
NCT Number NCT06891105
Lead Sponsor Mansoura University
Conditions Hemodialysis, Probiotics, Synbiotics, Nutritional Status
Enrollment 60 participants
Start Date 2025-04-15
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-24