Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Effects of a Probiotic Formulation in Hemodialysis Patients
Brief Summary: Previous studies found that lactic acid bacteria could inhibit the activity of the performance of aristolochic acids (AAs) and improve apoptosis of proximal tubular epithelial cells (NRK-52E) and renal fibrosis on rats. The aim of this study is to assessment a novel health food of lactic acid bacteria for preventing renal dysfunction and replacing or assisting conventional drug treatment. This study in 300 hemodialysis patients with dialysis quality assessment index (KT/V, urea reduction ratio (URR), albumin, prealbumin, Hb, CRP...) screened for more than three months, and the stability of the situation in dialysis patients. They will be divided into two groups in order to conduct ergonomic assessments. One group maintains their original diet and medicine. The other group will take the novel lactic acid bacteria and placebo (1x1011 cfu/3±0.2 g/bag) in every morning and evening after their meals. The effect of 0, 6, 12, 18, 24 weeks of the novel lactic acid bacteria will be assessed after starvation for 4 weeks. Group C was the control group did not give any test samples, but continued to observe. The overall goal of the aforementioned study is to develop a novel food product of lactic acid bacteria which can improve dialysis quality for hemodialysis patients. The investigators hope that this novel product can get a patent and be commercialized.


Options:
A: Inclusion Criteria:

* Adults
* Type 2 diabetic patients with stages 1 and 2 of nephropathy (defined as meeting criteria including fasting blood glucose \>126 mg/dL, hypoglycemic agents, or insulin intake, proteinuria \>300 mg/day, and glomerular filtration rate \>90 mL/min)

Exclusion Criteria:

* pregnancy or lactating in women
* allergy or intolerance to soy milk or avoidance of soy milk consumption
* smoking, alcoholism
* recent antibiotic therapy and using of supplements containing vitamins and minerals
* any medical condition such as inflammatory bowel disease, infection, liver disease and rheumatoid arthritis.
B: Inclusion Criteria:

1. Both sexes aged between 20-75 years.
2. Received stable hemodialysis at least 3 months.
3. Written informed consent.

Exclusion Criteria:

1. patients with severe infections, severe heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring oral nutrition supplements;
2. Inability to follow protocol.
3. patients with known gastro-intestinal disease (i.e.,inflammatory bowel disease,crohn's disease,ulcerative colitis)
4. Use of antibiotics, prebiotics or probiotics and immunosuppression medications in the past 4 weeks
5. Pregnancy or wishing/trying to get pregnant
C: Inclusion Criteria:

* stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),
* ages of 30-75 years old,
* Must be capable of complying with and following the study protocol(diet and exercise)
* Must be capable of independently giving informed consent

Exclusion Criteria:

* kidney transplant
* currently in a structured exercise program
* on antibiotic therapy within the last month
* On a probiotic or prebiotic supplement within the last month
* a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion
* HIV positive
* gastric by-pass surgery
* clostridium difficile
* marijuana user
* lupus
* rheumatoid arthritis
* Hepatitis C
* Post-traumatic stress disorder
* deep vein thrombosis
* pancreatitis
D: Inclusion Criteria:

* age \>18 years
* eGFR between 20 and 60 mL/min (stage 3-4 CKD, according to the K/DOQI CKD classification)

Exclusion Criteria:

* severe infections
* diabetes
* malignancy
* history of food intolerance
* autoimmune disorders
* severe malnutrition
* clinical conditions requiring artificial feeding
* kidney transplant

Answer: B