Clinical Trial

Effect of Gut Microbiome Intervention on Aging Via Oral FMT

Study acronym: STEP-aging
Recruiting Early Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-10-27; most recent amendment 2025-12-24.
Status change: Not Yet Recruiting → Recruiting 2025-12-24
Trial Details
NCT Number NCT05598112
Lead Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions Aging, Frailty
Enrollment 210 participants
Start Date 2023-04-24
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-31