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Table 1 The schedule of enrollment, interventions, and assessments

From: Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study

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   
  1. 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