End Stage Renal Disease (ESRD), Hemodialysis, Kidney Failure, Chronic
Conditions
Keywords
Probiotic, Synbiotic, Hemodialysis, Uremic toxins, p-Cresyl sulfate, Gut microbiota, End stage renal disease, Quality of life, Cognitive function, Randomized controlled trial
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNatural Probiotic Supplement
Oral natural probiotic supplementation was administered in addition to standard maintenance hemodialysis care for 6 months.
DIETARY_SUPPLEMENTNatural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber)
Oral synbiotic supplementation (natural probiotic plus prebiotic fiber \[oat\]) was administered in addition to standard maintenance hemodialysis care for 6 months.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
This was a single-blind randomized trial. Outcome assessors were blinded to group assignment. Echocardiography was performed and interpreted by cardiologists who were unaware of the intervention allocation.
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * End-stage renal disease patients on regular maintenance hemodialysis * Not under active preparation for kidney transplantation within the next year (i.e., not planned for transplantation for more than one year)
Exclusion criteria
* Age less than 18 years * Under active preparation for kidney transplantation * Pregnancy * Active malignancy * Known structural gastrointestinal tract disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum p-Cresyl Sulfate (PCS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (Kidney Disease Quality of Life-36) | 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. |
| Change in Cognitive Function (Montreal Cognitive Assessment) | 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. |
| Change in Left Ventricular Ejection Fraction (LVEF) | 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. |
| Change in Left Ventricular End-Diastolic Volume (LVEDV) | Baseline and 6 months | Left ventricular end-diastolic volume measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months. |
| Change in Left Ventricular End-Systolic Volume (LVESV) | Baseline and 6 months | Left ventricular end-systolic volume measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months. |
| Change in Left Ventricular Mass Index (LVMI) | Baseline and 6 months | Left ventricular mass index measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months. |
| Change in Blood Urea Nitrogen (BUN) | Baseline and 6 months | Blood urea nitrogen is measured in blood. The outcome is the change from baseline to 6 months. |
| Change in Serum Creatinine | Baseline and 6 months | Serum creatinine is measured in blood. The outcome is the change from baseline to 6 months. |
| Change in Serum Potassium | Baseline and 6 months | Serum potassium is measured in blood. The outcome is the change from baseline to 6 months. |
| Change in Serum Phosphorus | Baseline and 6 months | Serum phosphorus is measured in blood. The outcome is the change from baseline to 6 months. |
| Change in Hemoglobin | Baseline and 6 months | Hemoglobin is measured on a complete blood count. The outcome is the change from baseline to 6 months. |
Countries
Egypt
Outcome results
None listed