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

Table 1 The schedule of enrollment, interventions, and assessments

Workflow	*Enrollment*	*Allocation*	*Follow-up*					*Close-out*
Workflow	*− 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

ISSN: 1745-6215