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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04911556
Other study ID # Z202002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2022

Study information

Verified date May 2021
Source Wuxi People's Hospital
Contact Kan Hong, doctor
Phone 13358119885
Email 2898456291@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study intends to recruit aging population (over 65 years old). The investigators use 16 SrDNA sequencing technology, genome sequencing technology, metabonomics, random forest forecast model, analysing and selecting specific age-related intestinal flora. The investigators select probiotics slowing down senility. Then the investigators use the probiotics to intervene in the aging population. Finally the investigators observe whether the probiotics can delay aging.


Description:

This project plans to recruit the aging population (aged over 65 years old) and comprehensively analyze the public database and self-sequencing clinical big data by using 16 srDNA sequencing technology, metagenomic sequencing technology, metabonomics methods and Random Forest (R) prediction model to judge the key bacterial communities and related functional pathways related to aging.Based on the analysis results, the probiotics with the potential to alleviate aging were selected for intervention evaluation of aging population. This topic aims to explore the change process of intestinal flora structure and composition related to aging process.Identify the key intestinal bacteria genera/species/strains associated with aging, and target the pathway and metabolic characteristic spectrum of the key bacterial communities associated with aging;And select and breed specific intestinal bacterial strains related to aging.The aim is to reduce the age-related metabolic abnormalities and chronic inflammation, reduce medical treatment, rationally allocate medical resources, reduce medical costs and improve the quality of life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Over 65 years old 2. Frail scale score above 3 points Exclusion Criteria: 1. Severe impairment of liver and kidney function 2. The tumor is advanced and life expectancy is less than 2 years 3. Severe cognitive impairment and inability to cooperate 4. Unable to give informed consent 5. Have participated in other study before

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Bifidobacterium longum
types of intestinal flora
A placebo made of starch
placebo

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Wuxi People's Hospital Jiangnan University

Outcome

Type Measure Description Time frame Safety issue
Primary Points of probiotics intervention in aging population The score of Frail scale 0 points is defined as normal.And 1 to 3 points is defined as the early age of debility.Three points or more is defined as debility.The score is lower than before, meaning probiotic intervention can alleviate debility. one year
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