Gut Microbiota and Alzheimer's Diseases

Alzheimer Disease Clinical Trial

Official title:

Gut Microbiota and Alzheimer's Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827733
• Other study ID #: dsyy004
• Status: Recruiting
• Start date: February 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: Shanghai 10th People's Hospital
• Contact: Yuan Shen, MD, PhD
• Phone: 02166303649
• Email: kmshy[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• aged 60 and older

Exclusion Criteria:

• with other acute gastrointestinal diseases

• with other severe neuropsychiatric disorders

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut beta-amyloid 42	Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot.	Through study completion, an average of 4 year
Secondary	Gut microbiota	We will use DNA sequencing to define the profile of gut microbiota.	Through study completion, an average of 4 year
Secondary	Oral microbiota	We will use DNA sequencing to define the profile of gut microbiota.	Through study completion, an average of 4 year
Secondary	Cognitive function by Mini-mental State Examination (MMSE)	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).	through study completion, an average of 4 year