the Effect of Probiotics on Aging Population

Debility Clinical Trial

— TEOPOGP  

Official title:

Study for the Effect of Probiotics on Aging Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04911556
• Other study ID #: Z202002
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Debility

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