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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Maximum Age: 85
Healthy Volunteers: t
View:

• Age 70-85 years.

• Patients with informed consent after thorough explanation.

Locations
Other Locations
China
Beijing Chao-yang Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Hospital
RECRUITING
Beijing
Chinese People's Liberation Army (PLA) General Hospital
RECRUITING
Beijing
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Zhejiang Hospital
RECRUITING
Hangzhou
Huadong Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Luyun Fan, MD,PhD
katevan@163.com
01081992131
Backup
Jun Cai, MD,PhD
caijun7879@126.com
Time Frame
Start Date: 2023-04-24
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 210
Treatments
Experimental: FMT capsules
FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on week 0, week 4, week 8, week 12, week 24, week 28, week 32, week 36, week 48, week 52, week 56, week 60, week 72, week 76, week 80, week 84.
Placebo_comparator: Placebo capsules
Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on week 0, week 4, week 8, week 12, week 24, week 28, week 32, week 36, week 48, week 52, week 56, week 60, week 72, week 76, week 80, week 84.
Related Therapeutic Areas
Sponsors
Leads: Chinese Academy of Medical Sciences, Fuwai Hospital

This content was sourced from clinicaltrials.gov