Gut Microbiota and Alzheimer's Diseases

• Conditions: Alzheimer Disease

• Registration Number: NCT03827733
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

The investigator will perform clinical studies to test a hypothesis that participants who have Alzheimer's disease will have different gut/oral microbiota profile as compared to the participants who do not have Alzheimer's disease. The investigators will also check the microbiome of their partners in this study. The investigators plan to perform the studies in 150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai city. Investigators will also measure the beta-amyloid in the feces of the participants. Finally, the investigators will determine cognitive function in these participants.

Detailed Description

Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant impact on the behavior and brain pathology consistent with Alzheimer's disease (AD) neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome and feces beta-amyloid of AD patients are different from those of the participants without AD and their partners. The investigators plan to recruit 150 subjects, including three groups of normal elders, AD patients and the partners of the AD patients. The cognitive function will be assessed and the feces and oral samples will be collected to determine whether there are differences or correlations.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• aged 60 and older

Exclusion Criteria

• with other acute gastrointestinal diseases
• with other severe neuropsychiatric disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut beta-amyloid 42	Through study completion, an average of 4 year	Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot.

Secondary Outcome Measures

Name	Time	Method
Oral microbiota	Through study completion, an average of 4 year	We will use DNA sequencing to define the profile of gut microbiota.
Cognitive function by Mini-mental State Examination (MMSE)	through study completion, an average of 4 year	We will assess the cognitive function in the participants using MMSE to promote the diagnosis of AD in these participants. The sum of MMSE ranges from 0 (worse) to 30 (better).
Gut microbiota	Through study completion, an average of 4 year	We will use DNA sequencing to define the profile of gut microbiota.

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China