Actively Recruiting
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)
Led by Jining Medical University · Updated on 2025-02-20
285
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
J
Jining Medical University
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between gut microbiota dysfunction and Alzheimer's disease (AD), focusing on how gut-derived short-chain fatty acids (SCFAs) may influence brain function through the "gut microbiota-SCFAs-brain networks" pathway. This observational study will explore differences in SCFAs among people across the AD spectrum, including cognitively normal individuals, those with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. The project aims to clarify the interactions between gut microbiome, metabolites, and brain changes using high-throughput metabolomics and multi-modal MRI techniques. Participants will be grouped into four categories: cognitively normal, SCD, MCI, and AD dementia. The study involves collecting multi-omics data, including gut microbiome analysis, metabolomics, and neuroimaging, to establish a diagnostic model for SCD due to preclinical AD using machine learning methods. The study spans five years, during which gut microbiome changes, SCFAs levels, and multi-omics biomarkers related to cognitive impairment conversion will be monitored. Participants will undergo cognitive tests and brain imaging scans, along with gut microbiome and metabolite sample collection. Researchers will assess the interaction mechanisms of the gut microbiota-SCFAs-brain networks over five years. The study includes both healthy volunteers and patients aged 60 to 80. Outcome measures focus on changes in gut microbiome, SCFAs, and biomarkers linked to cognitive decline, with long-term follow-up to better understand the disease progression and its early detection.
CONDITIONS
Brief Title
A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cognitively normal participants with normal cognitive test performance and no memory complaints or concerns
- Participants with subjective cognitive decline (SCD) who have persistent memory decline, normal cognitive tests, no dementia or MCI, onset at age 60 or older within the last 5 years, with worries about their memory
- Participants with mild cognitive impairment (MCI) showing impaired scores in one or more cognitive domains and Functional Activities Questionnaire score of 9 or higher
- Participants with Alzheimer's dementia meeting dementia criteria, impaired daily function, episodic memory deficit, and Clinical Dementia Rating of 1 or higher
- Age between 60 and 80 years
You will not qualify if you...
- History of stroke
- Major depression or anxiety
- Other central nervous system disorders causing cognitive impairment such as Parkinson's disease, tumors, encephalitis, or epilepsy
- Cognitive impairment caused by traumatic brain injury
- Systemic diseases like thyroid dysfunction, syphilis, or HIV
- Psychosis or congenital mental developmental delay
- Use of antibiotics, probiotics, prebiotics, or synbiotics within the last 3 months
- Use of corticosteroids, immune stimulating medications, or immunosuppressive agents
- Major gastrointestinal surgery in the past 5 years
- Severe gastrointestinal diseases including irritable bowel syndrome, inflammatory bowel disease, severe gastritis, or other digestion and absorption dysfunctions affecting gut microbiota
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 years
Participants undergo multi-omics features extraction including clinical data, gut microbiome, metabolomics, and multi-modal MRI to establish diagnostic models and assess brain health.
Periodic assessments over 5 years
Duration - 5 years
Participants are monitored over time to observe changes in gut microbiome, SCFAs, and cognitive function across the spectrum of Alzheimer's disease.
Periodic follow-up visits during the 5-year study period
Trial Site Locations
Total: 1 location
1
Department of Neurolgy, the Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272029
Actively Recruiting
Research Team
C
Can Sheng, PhD
Y
Yun Guo, Master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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