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Gut Microbiota and Alzheimer's Diseases

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03827733
Collaborator
(none)
200
Enrollment
1
Location
58.9
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Gut Microbiota and Alzheimer's Diseases
    Actual Study Start Date :
    Feb 1, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    AD patients

    Participants who are diagnosed with AD.
    Partners of the AD patients

    Partners of AD patients who live together with the AD patients.
    Elderly participants with normal cognition

    Community dwelling elderly with normal cognition and with AD.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Gut microbiota [Through study completion, an average of 4 year]

      We will use DNA sequencing to define the profile of gut microbiota.

    2. Oral microbiota [Through study completion, an average of 4 year]

      We will use DNA sequencing to define the profile of gut microbiota.

    3. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • aged 60 and older
    Exclusion Criteria:

    • with other acute gastrointestinal diseases

    • with other severe neuropsychiatric disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Tenth People's Hospital Shanghai Shanghai China 200072

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    • Principal Investigator: Yuan Shen, MD, PhD, Shanghai 10th People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuan Shen, MD, PhD, Chief of Psychiatry Department, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03827733
    Other Study ID Numbers:
    • dsyy004
    First Posted:
    Feb 1, 2019
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yuan Shen, MD, PhD, Chief of Psychiatry Department, Shanghai 10th People's Hospital
    Gut Microbiota
    Alzheimer's Diseases
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Apr 19, 2021