Oral fecal microbiota transplant for healthier aging and reduced frailty

Effect of Fecal Microbiota Transplantation on Aging and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial

This trial will try oral fecal microbiota transplant capsules in people aged 70–85 to test whether changing the gut microbiome improves frailty, cognitive and physical measures of aging.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 70 Years to 85 Years
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Academic / other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT05598112 on ClinicalTrials.gov

What this trial studies

This is a multi-center, randomized, blinded, placebo-controlled early-phase pilot testing oral fecal microbiota transplant (FMT) capsules versus placebo in older adults. Participants aged 70–85 will receive FMT or placebo capsules and undergo repeated assessments of frailty, physical function, cognition, imaging (hippocampal volume), telomere length, inflammatory and cognitive biomarkers, and gut microbial composition and metabolites. Safety and tolerability will be monitored closely and data quality is overseen by independent statisticians and a third-party monitor. The trial is designed to explore both clinical effects and potential biological mechanisms linking the gut microbiome to aging-related measures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 70–85 who can give informed consent and do not have recent antibiotic/probiotic use, severe liver or kidney disease, recent major cardiac events, or major recent strokes.

Not a fit: People outside the 70–85 age range or those with serious hepatic/renal failure, recent antibiotics or probiotics use, recent major cardiac or cerebrovascular events, or current participation in other trials are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could improve frailty, physical and cognitive function, and biological markers of aging in older adults.

How similar studies have performed: Preclinical studies and some clinical work support microbiome approaches and oral FMT is established for infections, but using oral FMT specifically to target aging and frailty in humans is largely novel with limited direct human evidence.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

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

Study contacts

• Principal investigator: Jun Cai, MD,PhD — Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Chinese Institutes for Medical Research
• Study coordinator: Luyun Fan, MD,PhD

Conditions Aging; Frailty; Microbiome; Treatment; Fecal Microbiota Transplantation