{"type":"trials","record":{"id":21691,"source_id":"clinicaltrials-gov","external_id":"NCT05598112","title":"Effect of Gut Microbiome Intervention on Aging Via Oral FMT","brief_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.","overall_status":"Recruiting","phases":["EARLY_PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Chinese Academy of Medical Sciences, Fuwai Hospital","enrollment":210,"countries":["China"],"start_date":"2023-04-24","completion_date":"2027-12-31","last_update_date":"2025-12-31","source_url":"https://clinicaltrials.gov/study/NCT05598112","editorial_summary":"A registered EARLY_PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:08.972024+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"STEP-aging","age_range":"70 Years to 85 Years","comparator":"Placebo capsules","organization":"Chinese Academy of Medical Sciences, Fuwai Hospital","interventions":["FMT capsules","Placebo capsules"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Proportion of participants with reduced frailty score at week 96 follow-up — week 96","Proportion of participants with reduced frailty score at week 12 follow-up — week 12","Proportion of participants with reduced frailty score at week 24 follow-up — week 24","Proportion of participants with reduced frailty score at week 48 follow-up — week 48","Proportion of participants with reduced frailty score at week 72 follow-up — week 72","Change from baseline in Frailty score — week 12, week 24, week 48, week 72, week 96, compared with baseline","Change from baseline in telomere length — week 48, week 96","Change from baseline in Cognitive assessment via Mini Mental State Examination(MMSE) — week 24, week 48, week 72, week…","Change from baseline in Cognitive assessment via Montreal Cognitive Assessment(MoCA) — week 24, week 48, week 72, week…","Change from baseline in Hippocampal volumes — week 48, week 96","Change from baseline in cognitive biomarkers — week 12, week 24, week 48, week 72, week 96","Change from baseline in inflammatory biomarkers — week 12, week 24, week 48, week 72, week 96","Change from baseline in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis — week 12…","Change from baseline in Intestinal Microbiota Function assessed by KEGG Orthology (KO) Pre- and Post-intervention via M…","Change from baseline in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis — week 12, we…","Change from baseline in Ankle-Brachial Blood Pressure Index(ABI) — week 48, week 96","Change from baseline in Pulse wave velocity(PWV) — week 48, week 96","Number of Participants with Adverse Events (AEs) as a Measure of Safety — week 12, week 24, week 48, week 72, week 96","Change from baseline in Body Mass Index (BMI) — week 4, week 8, week 12, week 24, week 48, week 72, week 96","Change from baseline in office SBP — week 4, week 8, week 12, week 24, week 48, week 72, week 96"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Aging","Frailty","FMT capsules","Placebo capsules"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: microbiome.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct05598112","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-04-24 to 2027-12-31","comparator":"Placebo capsules","confidence":"structured-source","population":"ALL · 70 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.472Z","intervention":["FMT capsules","Placebo capsules"],"participants":210,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"EARLY_PHASE1","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Proportion of participants with reduced frailty score at week 96 follow-up — week 96","Proportion of participants with reduced frailty score at week 12 follow-up — week 12","Proportion of participants with reduced frailty score at week 24 follow-up — week 24","Proportion of participants with reduced frailty score at week 48 follow-up — week 48","Proportion of participants with reduced frailty score at week 72 follow-up — week 72","Change from baseline in Frailty score — week 12, week 24, week 48, week 72, week 96, compared with baseline","Change from baseline in telomere length — week 48, week 96","Change from baseline in Cognitive assessment via Mini Mental State Examination(MMSE) — week 24, week 48, week 72, week…","Change from baseline in Cognitive assessment via Montreal Cognitive Assessment(MoCA) — week 24, week 48, week 72, week…","Change from baseline in Hippocampal volumes — week 48, week 96","Change from baseline in cognitive biomarkers — week 12, week 24, week 48, week 72, week 96","Change from baseline in inflammatory biomarkers — week 12, week 24, week 48, week 72, week 96","Change from baseline in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis — week 12…","Change from baseline in Intestinal Microbiota Function assessed by KEGG Orthology (KO) Pre- and Post-intervention via M…","Change from baseline in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis — week 12, we…","Change from baseline in Ankle-Brachial Blood Pressure Index(ABI) — week 48, week 96","Change from baseline in Pulse wave velocity(PWV) — week 48, week 96","Number of Participants with Adverse Events (AEs) as a Measure of Safety — week 12, week 24, week 48, week 72, week 96","Change from baseline in Body Mass Index (BMI) — week 4, week 8, week 12, week 24, week 48, week 72, week 96","Change from baseline in office SBP — week 4, week 8, week 12, week 24, week 48, week 72, week 96"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"microbiome-dysbiosis","is_published":true,"match_reasons":["Title contains controlled term: microbiome.","Abstract contains controlled term: microbiome.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Microbiome and dysbiosis","slug":"microbiome-dysbiosis"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21691","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}