Effect of Gut Microbiome Intervention on Aging Via Oral FMT

Objective: To explore the effect, safety and underlying mechanisms of gut microbiome intervention via FMT on aging. Study Design: A multi-center, randomized, blinded, placebo-controlled pilot study. Data quality control and statistical analysis: The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality. Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.

Inclusion criteria

• Age 70-85 years.
• Patients with informed consent after thorough explanation.

Exclusion criteria

• Participants of other clinical trials;
• Antibiotics or probiotics usage within last 4 weeks;
• Severe 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 6 months;
• 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;
• History of dementia, Parkinson's disease, intracranial infection, intracranial tumor, schizophrenia, anxiety, depression;
• History of neurosurgical operation;
• History of gastrointestinal tumor, gastrointestinal surgery, inflammatory bowel disease; Hospitalization for peptic ulcer disease exacerbation within last 6 months or anticipated hospitalization for peptic ulcer disease the next 6 months;
• Hypertension with uncontrolled blood pressure ≥180/110mmHg;
• Diabetes Mellitus with uncontrolled fasting glucose level ≥200mg/dl (11.1mmol/L), or HbA1C>8%;
• Addicted to alcohol; Use of medication influencing cognitive function(i.e., antihistamine, antipsychotic);
• General anesthesia within last 3 months;
• Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome, life expectancy <1 year;
• Impaired verbal communication who are incapable of providing their own informed consent, or incapable of self-care;
• Special diet influencing microbiota (i.e. vegetarian);
• Other conditions inappropriate for recruitment according to the investigators.