Effect of Intensive FMT on Primary Hypertension

Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can be a potential approach to ameliorate hypertension. This study will perform intense fecal microbiota transplantation (FMT) intervention via oral capsules, in comparison with placebo capsules, to investigate the effect, safety and underlying mechanisms of gut microbiome intervention on primary hypertension.

Inclusion Criteria:Age 18~65 years.Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP<160mmHg and/or 90mmHg≤ Office DBP<100mmHg for three measurements at different days without any antihypertensive medications, according to the"2010 Chinese Guidelines for Prevention and Treatment of Hypertension".Patients with informed consent after thorough explanation.Exclusion Criteria:Antibiotics or probiotics usage within last 4 weeksParticipants of other clinical trials related to hypertension currently or within last 3 monthsAntihypertensive medications usage currently or within last monthDiagnosed secondary hypertensionSevere hepatic or renal diseases ((ALT >3 times the upper limit of normal value, or end stage renal disease on dialysis or eGFR <30 mL/min/1.73 m2, or serum creatinine >2.5 mg/dl [>221 μmol/L])History of large atherosclerotic cerebral infarction or hemorrhagic stroke(not including lacunar infarction and transient ischemic attack [TIA])Hospitalization for myocardial infarction within last 6 months; Coronary revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the next 12 months.Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement.NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months.Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period.Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease.Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome.Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent.Participants preparing for or under pregnancy and/or lactation.Other conditions inappropriate for recruitment according to the investigators.