Effect of Gut Microbiome Intervention on Aging Via Oral FMT

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Aging, Frailty

In brief

A severe public health issue facing global population is aging. Increasing preclinical and clinical data indicate the contribution of gut microbiome on aging and aging-related diseases such as cardiovascular disease, Alzheimer Disease, and diabetes. Interventions on microbiota are developed including prebiotics, probiotics, and fecal microbial transplantation (FMT). FMT via oral capsules also advances in recent with limited safety concerns compared with invasive routes. A hypothesis is thus raised that gut microbiome intervention via oral FMT can be a potential safe approach to encourage healthy aging, with multiple aspects evaluated for clinical phenotype of frailty, anthropometric measurement, cognitive function, cardiovascular aging, physical function, living activity, hippocampal volume, telomere length, cognitive biomarkers, inflammatory biomarkers, altered microbial composition and metabolites.

Key facts

Study ID

NCT05598112

Run by

Chinese Academy of Medical Sciences, Fuwai Hospital

People needed

210

Starts

2023-04-24

Expected to finish

2027-12-31

Last updated by the study team

2025-12-31

Who can join

Age: 70 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Beijing Chao-yang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Hospital — Beijing, Beijing Municipality, China (enrolling)
• Chinese People's Liberation Army (PLA) General Hospital — Beijing, Beijing Municipality, China (enrolling)
• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Huadong Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Zhejiang Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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