Effect of Gut Microbiome Intervention on Aging Via Oral FMT

ConditionsAgingFrailty
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age70-85
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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 criteria

Qualifiers

Age 70-85 years.

Patients with informed consent after thorough explanation.

Disqualifiers

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]);

Trial design

Treatments tested in this trial

  • FMT capsules
  • Placebo capsules

Treatment groups

210 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital

Lead sponsor

Beijing Anzhen Hospital

Sponsor institution