Please select the eligibility criteria that correspond 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: Inclusion Criteria:

1. Established type 2 diabetes with at least 6 months diagnosis
2. Age between 30 and 65 years
3. Hb A1c of less than 10% and fasting blood glucose less than 15mmol/l
4. BMI between 18.5-35 kg/ m2
5. Have not on any probiotics for the last 2 months prior to the recruitment
6. Ability to comply to the study protocol
7. They are treated with stabilized dose of medications (either receiving Sulphonylurea or Biguanides or both)

Exclusion Criteria:

1. Pregnancy and lactating (subjects will be excluded if they getting pregnant during course of study)
2. Having advanced diabetes complications except for hypertension and hyperlipidemia
3. Having acute or chronic illness (such as flu, cancer or arthritis rheumatoid) during the study recruitment which may affect carbohydrate metabolism
4. Language barriers which cannot be overcome via available resources
5. Currently being treated with any oral anti-diabetes agents other than Sulphonylurea or Biguanides or being treated with insulin
6. Using any medication such as steroids or antibiotics which might affect viability of gut microorganism at recruitment and during intervention phase.
B: Inclusion Criteria:

* Adult end-stage renal disease patients maintained on regular hemodialysis

Exclusion Criteria:

* Chronic liver disease
* Malignant condition
* Inflammatory bowel disease
* History of bowel resection
* Long term antibiotic therapy
* Pregnancy or lactation
* Current use of immunosuppressive medication
C: Inclusion Criteria:

* Adult subjects (\>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion.
* At least one of these caloric malnutrition criteria: a) involuntary weight loss \>5% in 3 months or \>10% in 6 months; b) serum albumin \< 3.5 g/dl or prealbumin \<28 mg/dl; c) body mass index (BMI) \< 23 kg/m2; d) muscular mass loss \>5% in 3 months or \>10% in 6 months.
* Standard hemodialysis therapy (3 days/week, 240 min, high permeability dialyzer, blood flow \>250 ml/min and dialysate flow 500 ml/min) or on-line hemodialysis therapy that was not modified in the last 3 months previous to the inclusion.
* Written informed consent obtained.

Exclusion Criteria:

* Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c\>9%.
* Unstable dry weight.
* Limb amputation.
* Significant edema.
* Active malignancy.
* Hospital admissions in the last 3 months.
* Acute gastrointestinal disease in the 2 weeks before the inclusion.
* Gastrectomy, gastroparesis or abnormal gastric emptying.
* Acute heart failure grade IV.
* Severe hepatic insufficiency (men gamma glutamyl transferase -GGT- \>150 U/l, women \>120 U/l).
* Alcohol or other drugs abuse.
* Participants enrolled in other research study at inclusion.
* Pregnant women.
* No informed consent obtained.
* Patients who received any oral nutritional supplement (specific for hemodialysis patients or not) in the 4 weeks before the inclusion.
* Patients receiving enteral tube feeding.
* Galactosemia, fructosemia, or requirement of a no fiber diet.
* Allergy or hypersensitivity to any ingredient of the oral nutritional supplement.
* Ongoing treatment with glucocorticoids.
* Patients who received any oral fatty acids omega-3 supplement in the 4 weeks before the inclusion.
* Patients who received intradialytic parenteral nutrition in the 3 months before the inclusion.
* Patients who received any probiotics or prebiotics (not as part of the diet) in the 3 months before the inclusion.
* Anemia (Hemoglobin \< 10 g/dl) or Epoetin resistance.
D: Inclusion Criteria:

* \>3 months on automated peritoneal dialysis treatment
* Signed informed consent

Exclusion Criteria:

* ESRD of inflammatory cause (lupus, vasculitis, collagenopathies)
* Intake of probiotics, prebiotics or fiber in the last 3 months
* Use of anti-inflammatory drugs or nutritional supplements (immunossuppresants, pentoxifylline, NSAIDs, omega-3)
* Treated with antibiotics or sevelamer
* Treated with research drugs or participants in any clinical trial
* Peritonitis or active infection 2 weeks prior the study
* Any medical condition affecting intestinal absorption (inflammatory bowel disease, short bowel syndrome, bariatric surgery) or severe dysmotility
* Severe malnutrition
* Previous kidney transplantation
* Serious diseases altering the fina outcomes of the study: decompensated heart failure, chronic liver disease, cancer, AIDS.

Answer: D