Table 1.
Workflow | Enrollment | Allocation | Follow-up | Close-out | ||||
---|---|---|---|---|---|---|---|---|
− 7 days | Day 0 | Day 1 | Day 7 | Day 14 | Day 30 | Day 60 | Day 90 | |
Enrollment | ||||||||
Eligibility screening | ✓ | |||||||
Informed consent | ✓ | |||||||
Allocation | ✓ | |||||||
Interventions | ||||||||
FMT capsules | ✓ | ✓ | ✓ | |||||
Placebo capsules | ✓ | ✓ | ✓ | |||||
Assessments | ||||||||
Comorbid diseases and treatment | ✓ | |||||||
Physical examination | ✓ | ✓ | ||||||
Office BP and heart rate | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
24-h ABPM | ✓ | ✓ | ✓ | |||||
Blood routine | ✓ | ✓ | ||||||
Urine routine | ✓ | ✓ | ||||||
Blood chemical test | ✓ | ✓ | ||||||
Urine microalbumin, creatinine | ✓ | ✓ | ||||||
ECG | ✓ | ✓ | ||||||
Arterial stiffness (ABI, PWV) | ✓ | ✓ | ||||||
Diet records | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Patient compliance | ✓ | ✓ | ✓ | |||||
Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Combined medications for accompanied diseases | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Fecal sample collection | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Blood sample collection | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Blood biochemical test: ALT alanine aminotransferase, AST aspartate aminotransferase, K potassium, Na sodium, Cl chloride, BUN urea nitrogen, CREA creatinine, UA uric acid, TC total cholesterol, TG triglyceride, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, GLU fasting blood glucose