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RECRUITING
NCT05598112
EARLY_PHASE1

Effect of Gut Microbiome Intervention on Aging Via Oral FMT

Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Fecal Microbiota Transplantation on Aging and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial

Key Details

Gender

All

Age Range

70 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2023-04-24

Completion Date

2027-12-31

Last Updated

2025-12-31

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

FMT capsules

FMT capsules containing extensively screened donor stool.

OTHER

Placebo capsules

Placebo capsules that do not contain donor stool or any active drug.

Locations (6)

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Zhejiang Hospital

Hangzhou, Zhejiang, China