Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of a Nutritional Supplement of Probiotics and/or Prebiotics vs Placebo on Serum Concentrations of Uremic Toxins and Inflammatory Cytokines in Automated Peritoneal Dialysis Patients.
Brief Summary: End-stage renal disease (ESRD) is a world public health problem, with high morbidity and mortality. Cardiovascular disease is the main cause of mortality in ESRD; uremic toxin retention and inflammation are considered non-traditional risk factors, as they have an active role in atherosclerosis and vascular calcification pathogenesis in dialysis patients.

Uremic toxins may be generated by internal protein metabolism, however, some toxins that can't be efficiently eliminated by dialysis such as indoxyl sulphate and p-cresyl sulphate (protein bound toxins), are generated by the microbial metabolism in the large intestine by proteolytic bacteria, and may diffuse easily through the intestinal lumen, as a leaky gut characterizes kidney disease.

The gut has been recognized as a potential source of inflammation in ESRD patients; accumulation of nitrogen compounds, presence of gastrointestinal symptoms, dietary changes and multiple drugs and supplements use, stimulates microbiota alterations as bacterial overgrowth and translocation. These phenomena, may active the immune system, promoting local and systemic inflammation, which in turn has negative effects increasing endothelial dysfunction, muscle catabolism, insulin and erythropoietin resistance, and decreases appetite.

Some methods have been proposed to decrease inflammation and uremic toxin accumulation, as more efficient dialysis and anti-inflammatory drugs; however, some of them have limited efficacy and high cost. Nutritional treatments focused on modifying intestinal environment, as pre- and probiotics have promising effects by altering production and absorption of uremic toxins and decreasing inflammation; nevertheless, there is scarce information regarding its use and their role in ESRD, particularly in peritoneal dialysis, which is a widely used therapy in México. Furthermore, there is no clinical study comparing the effectiveness of prebiotics, probiotics, and symbiotics on serum concentrations of uremic toxins and inflammation in ESRD patients. It is possible that the administration of a nutritional supplement of probiotics and/or prebiotics decreases the serum concentrations of uremic toxins and inflammation markers in ESRD patients on automated peritoneal dialysis compared to placebo.


Options:
A: Arm Label: probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic; Assigned to Arm(s): probiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): placebo
B: Arm Label: A; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Gum Arabic | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: C; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Gum Arabic | Arm Label: D; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Gum Arabic | Intervention Type: DIETARY_SUPPLEMENT; Name: Gum Arabic; Assigned to Arm(s): A, C, D | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): B
C: Arm Label: Oral nutritional supplement with probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement with probiotics | Arm Label: Oral nutritional supplement without probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement without probiotics | Arm Label: Individualized dietary recommendations; Type: ACTIVE_COMPARATOR; Interventions: Other: Dietary recommendations | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement with probiotics; Assigned to Arm(s): Oral nutritional supplement with probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement without probiotics; Assigned to Arm(s): Oral nutritional supplement without probiotics | Intervention Type: OTHER; Name: Dietary recommendations; Assigned to Arm(s): Individualized dietary recommendations
D: Arm Label: Probiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Probiotic | Arm Label: Prebiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Prebiotic | Arm Label: Symbiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Symbiotic | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic; Assigned to Arm(s): Probiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Prebiotic; Assigned to Arm(s): Prebiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Symbiotic; Assigned to Arm(s): Symbiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D