NCT06837272

A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease

A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease: China Healthy Brain and Gut Microbiome Study (CHBGMS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 285 (estimated)
• Sponsor: Jining Medical University · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Gut microbiota dysfunction is associated with Alzheimer's disease (AD). However, the potential modulatory mechanism remains unclear. Previous studies have shown that gut-derived metabolites short-chain fatty acids (SCFAs) may be the key mediators between gut microbiota and brain, participating in the modulatory pathway "gut microbiota-SCFAs-brain networks". In this project, high-throughput targeted metabolomics technique will be used to explore the differences of SCFAs in the spectrum of AD, including cognitively normal individuals, subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. Then, the gut microbiome and multi-modal MRI techniques will be combined to elucidate potential interaction mechanisms of "gut microbiota-SCFAs-brain networks". Finally, based on multi-omics features extracted from gut microbiome, metabolomics, and neuroimaging after five years, the diagnostic model of SCD due to preclinical AD will be established using machine learning methods.

Conditions

• Alzheimer Disease
• Gut Microbiota
• Metabonomics
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multi-omics features extraction	Based on multi-omics features extracted from clinical data, gut microbiome, metabolomics, and multi-modal MRI, the diagnostic model of SCD due to preclinical AD will be established.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: China