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Recruiting Early Phase 1

Effect of Gut Microbiome Intervention on Aging Via Oral FMT

NCT05598112 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2023-04-24
Last updated
2025-12-31

Condition(s) studied

AgingFrailty

Investigational drug(s) / intervention(s)

FMT capsulesPlacebo capsules

FMT capsules: FMT capsules containing extensively screened donor stool.

Placebo capsules: Placebo capsules that do not contain donor stool or any active drug.

Study summary

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.

Eligibility

Sex
ALL
Min age
70 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age 70-85 years. 2. Patients with informed consent after thorough explanation. Exclusion Criteria: 1. Participants of other clinical trials; 2. Antibiotics or probiotics usage within last 4 weeks; 3. 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 \[\>221 μmol/L\]); 4. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack \[TIA\]); 5. 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; 6. NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months; 7. Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period; 8. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease; 9. History of dementia, Parkinson's disease, intracranial infection, intracranial tumor, schizophrenia, anxiety, depression; 10. History of neurosurgical operation; 11. 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; 12. Hypertension with uncontrolled blood pressure ≥180/110mmHg; 13. Diabetes Mellitus with uncontrolled fasting glucose level ≥200mg/dl (11.1mmol/L), or HbA1C\>8%; 14. Addicted to alcohol; Use of medication influencing cognitive function(i.e., antihistamine, antipsychotic); 15. General anesthesia within last 3 months; 16. Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome, life expectancy \<1 year; 17. Impaired verbal communication who are incapable of providing their own informed consent, or incapable of self-care; 18. Special diet influencing microbiota (i.e. vegetarian); 19. Other conditions inappropriate for recruitment according to the investigators.

Primary outcome measure(s)

  • Proportion of participants with reduced frailty score at week 96 follow-up — week 96
    Frailty score via CHS criteria of five frailty components, compared with baseline

Trial sites (6)

FacilityCityRegionStatus
Beijing Chao-yang Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Hospital Beijing Beijing Municipality Recruiting
Chinese People's Liberation Army (PLA) General Hospital Beijing Beijing Municipality Recruiting
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Huadong Hospital Affiliated to Fudan University Shanghai Shanghai Municipality Recruiting
Zhejiang Hospital Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05598112 on ClinicalTrials.gov ↗ ← All trials in China