Urology and Nephrology Center (UNC), Mansoura University
Al Mansurah, Dakahlia Governorate, 35111, Egypt
NCT Number: NCT07531186
This single-center randomized controlled trial evaluated the effects of natural probiotic and synbiotic supplementation on clinical and biochemical characteristics in adults with end-stage renal disease receiving maintenance hemodialysis at the Urology and Nephrology Center, Mansoura University, Egypt. Participants were randomized into three groups (control, probiotic, and synbiotic), with supplementation given for 6 months in the intervention groups. The study assessed changes in uremic toxins (including p-cresyl sulfate) as the primary outcome, and cardiovascular parameters, quality of life, and cognitive function as secondary outcomes. The trial aimed to determine whether modulation of gut microbiota with probiotics or synbiotics can improve outcomes in hemodialysis patients
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Notify Me18 month and older
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, 35111, Egypt
End-stage renal disease patients receiving hemodialysis commonly have intestinal dysbiosis and accumulation of gut-derived uremic toxins. Probiotic and synbiotic supplementation may help modulate gut microbiota and reduce uremic toxin burden, but direct comparative data between probiotic and synbiotic strategies in hemodialysis patients are limited. This study was designed to assess the effects of natural probiotic and synbiotic administration on the clinical and biochemical characteristics and uremic toxin levels of hemodialysis patients at the Urology and Nephrology Center (UNC), Mansoura University, Egypt.
This was a single-center randomized controlled trial with single-blind allocation. Sixty adult patients with end-stage renal disease on regular hemodialysis were included (dropout-inflated sample size; calculated minimum sample size was 48). Participants were randomized into three groups: a control group (20 patients), a probiotic group (20 patients), and a synbiotic group (20 patients). The probiotic and synbiotic groups received supplementation for 6 months; the synbiotic intervention included natural probiotic supplementation combined with prebiotic fibers (oat). Regular hemodialysis was standardized during the trial (3 sessions/week, 4 hours/session).
The primary outcome was the effect of probiotic and synbiotic supplementation on uremic toxin levels, including p-cresyl sulfate. Secondary outcomes included cardiovascular-related parameters and comorbid clinical measures, including body mass index, anemia/ESA resistance, quality of life, and cognitive function. Assessments included laboratory testing (biochemical parameters and uremic toxins), echocardiographic evaluation by blinded cardiologists, and psychological assessment using cognitive testing (MOCA) and quality-of-life evaluation (KDQOL-36).
The completed thesis reports that both probiotic and synbiotic supplementation reduced serum p-cresyl sulfate compared with control, with a more pronounced reduction in the synbiotic group, and that some cardiovascular and quality-of-life parameters improved, while cognitive and other secondary outcomes were less pronounced. Baseline characteristics were comparable across groups, supporting successful randomization.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral natural probiotic supplementation was administered in addition to standard maintenance hemodialysis care for 6 months.
Oral synbiotic supplementation (natural probiotic plus prebiotic fiber [oat]) was administered in addition to standard maintenance hemodialysis care for 6 months.
Time frame: Baseline and 6 months
Serum p-cresyl sulfate level is measured in blood. Outcome is the change from baseline to the end of the intervention.
Time frame: Baseline and 6 months
Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire. Scores are reported for the KDQOL-36 subscales: Symptom/Problem List (0-100), Effects of Kidney Disease (0-100), and Burden of Kidney Disease (0-100), and the generic health components derived from the SF-12 (Physical Component Summary and Mental Component Summary). For the 0-100 KDQOL-36 subscales, higher scores indicate better quality of life (fewer symptoms/less burden). The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
The Montreal Cognitive Assessment (MoCA) is a screening test of global cognitive function. Total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Outcome is a change in the MoCA total score from baseline to 6 months.
Time frame: Baseline and 6 months
Left ventricular ejection fraction measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months. A higher percentage indicates better systolic function.
Time frame: Baseline and 6 months
Left ventricular end-diastolic volume measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
Left ventricular end-systolic volume measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
Left ventricular mass index measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
Blood urea nitrogen is measured in blood. The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
Serum creatinine is measured in blood. The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
Serum potassium is measured in blood. The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
Serum phosphorus is measured in blood. The outcome is the change from baseline to 6 months.
Time frame: Baseline and 6 months
Hemoglobin is measured on a complete blood count. The outcome is the change from baseline to 6 months.
Mansoura University
Other
Effects of Probiotic and Synbiotic Administration on the Clinical and Biochemical Characteristics of Hemodialysis Patients: A Randomized Controlled Trial
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