Oral fecal microbiota transplant for healthier aging and reduced frailty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: katevan@163.com
• Phone: 01081992131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.