the Effect of Probiotics on Aging Population

Not Applicable

• Conditions: Debility
• Interventions: Dietary Supplement: Bifidobacterium longum; Dietary Supplement: A placebo made of starch

• Registration Number: NCT04911556
• Lead Sponsor: Wuxi People's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-12
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bifidobacterium longum group 2	Bifidobacterium longum	Bifidobacterium longum 4-1
the placebo group	A placebo made of starch	A placebo made of starch
Bifidobacterium longum group 1	Bifidobacterium longum	Bifidobacterium longum 274
Bifidobacterium longum group 3	Bifidobacterium longum	Bifidobacterium longum gs

Primary Outcome Measures

Name	Time	Method
Points of probiotics intervention in aging population	one year	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.