NCT06837272Recruiting
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)
Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 285 (estimated)
- First submitted
- 15 Feb 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Jining Medical University
- Diseases
- Alzheimer disease
- NCT number
- NCT06837272
What you commit to
- Study type: Observational
- Planned participants: 285
- From 1 Jan 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- the use of corticosteroid, immune stimulating medications, and immunosuppressive agents;
- major gastrointestinal tract surgery in past 5 years;
Other illness
- a history of stroke;
- other central nervous system disorders that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis, and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
- a history of using antibiotics, probiotics, prebiotics, or synbiotics within 3 months;
- severe gastrointestinal diseases, such as irritable bowel syndrome, infammatory bowel disease, severe gastritis, other dysfunction in digestion and absorption, which has been reported to infuence gut microbiota
Other
- major depression and anxiety;
- psychosis or congenital mental developmental delay;
Who the study is looking for
- Cognitively normal group:
- normal performance on standardized cognitive tests;
- with no cognitive complaints or any concerns (worries).
- SCD group:
- self-experienced persistent decline in memory, rather than other domains of cognition;
- normal performance on standardized cognitive tests;
- failure to meet the criteria for MCI or dementia;
- age at onset of SCD ≥ 60 years old;
- onset of SCD within the last 5 years;
- concerns (worries) associated with SCD;
- feeling of worse performance than others of the same age group.
- MCI group:
- having impaired scores on both measures in at least one cognitive domain (memory, language, or speed/executive function);
- having impaired scores in each of the three cognitive domains (memory, language, or speed/executive function);
- the Functional Activities Questionnaire (FAQ)≥9.
- AD dementia group:
- meet the criteria for dementia and have impaired daily functional activities;
- episodic memory deficit; 3) Clinical Dementia Rating (CDR) ≥ 1.
Age in the registry: 60 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurolgy, the Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.