Gut Microbiota and Alzheimer's Diseases

NCT ID: NCT03827733

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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AD patients

Participants who are diagnosed with AD.

No interventions assigned to this group

Partners of the AD patients

Partners of AD patients who live together with the AD patients.

No interventions assigned to this group

Elderly participants with normal cognition

Community dwelling elderly with normal cognition and with AD.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* aged 60 and older

Exclusion Criteria

* with other acute gastrointestinal diseases
* with other severe neuropsychiatric disorders
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuan Shen, MD, PhD

Chief of Psychiatry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuan Shen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Shen, MD, PhD

Role: CONTACT

02166303649

Zhongyong Shi, MD

Role: CONTACT

18701915271

Facility Contacts

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Yanxia Guo, M.D.

Role: primary

021-65982875

Other Identifiers

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dsyy004

Identifier Type: -

Identifier Source: org_study_id

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