Actively Recruiting
Effect of Gut Microbiome Intervention on Aging Via Oral FMT
Led by Chinese Academy of Medical Sciences, Fuwai Hospital · Updated on 2025-12-31
210
Participants Needed
6
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Gut Microbiome Intervention on Aging Via Oral FMT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70-85 years.
- Patients with informed consent after thorough explanation.
You will not qualify if you...
- Participation in other clinical trials.
- Use of antibiotics or probiotics within the last 4 weeks.
- Severe liver or kidney diseases such as ALT more than 3 times the upper limit, end stage renal disease on dialysis, eGFR less than 30 mL/min/1.73 m2, or serum creatinine over 2.5 mg/dl.
- History of large atherosclerotic cerebral infarction or hemorrhagic stroke (excluding lacunar infarction and transient ischemic attack).
- Hospitalization for myocardial infarction within the last 6 months or coronary revascularization within the last 12 months or planned in the next 6 months.
- NYHA class III-IV heart failure or hospitalization for chronic heart failure exacerbation within last 6 months.
- Severe valvular diseases with potential for surgery or valve replacement during study.
- Dilated cardiomyopathy, hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease.
- History of dementia, Parkinson's disease, intracranial infection, intracranial tumor, schizophrenia, anxiety, or depression.
- History of neurosurgical operation.
- History of gastrointestinal tumor, gastrointestinal surgery, inflammatory bowel disease; recent or anticipated hospitalization for peptic ulcer disease.
- Uncontrolled hypertension (blood pressure ≥180/110 mmHg).
- Uncontrolled diabetes mellitus (fasting glucose ≥200 mg/dl, HbA1C >8%).
- Alcohol addiction or use of medications affecting cognitive function.
- General anesthesia within the last 3 months.
- Other severe diseases affecting survival or study entry such as cancer or AIDS with life expectancy less than 1 year.
- Impaired verbal communication or inability to provide informed consent or self-care.
- Special diets affecting microbiota (e.g., vegetarian).
- Other conditions deemed inappropriate by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
5
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
6
Zhejiang Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Luyun Fan, MD,PhD
CONTACT
J
Jun Cai, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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