Effect of Gut Microbiome Intervention on Aging Via Oral FMT (NCT05598112) | Clinical Trial Compass
RecruitingEarly Phase 1
Effect of Gut Microbiome Intervention on Aging Via Oral FMT
China210 participantsStarted 2023-04-24
Plain-language 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.
Who can participate
Age range70 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age 70-85 years.
✓. Patients with informed consent after thorough explanation.
Exclusion criteria
✕. 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 \[TIA\]);
✕. 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;
✕. NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months;
✕
What they're measuring
1
Proportion of participants with reduced frailty score at week 96 follow-up
Timeframe: week 96
Trial details
NCT IDNCT05598112
SponsorChinese Academy of Medical Sciences, Fuwai Hospital