the Effect of Probiotics on Aging Population

NCT ID: NCT04911556

Last Updated: 2021-06-03

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

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Debility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group served as a control group, while the other three groups are treated with different strains of bifidobacterium longum
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participant ,care provider,investigator and outcomes Assessor are all blind.

Study Groups

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the placebo group

A placebo made of starch

Group Type PLACEBO_COMPARATOR

A placebo made of starch

Intervention Type DIETARY_SUPPLEMENT

placebo

Bifidobacterium longum group 1

Bifidobacterium longum 274

Group Type EXPERIMENTAL

Bifidobacterium longum

Intervention Type DIETARY_SUPPLEMENT

types of intestinal flora

Bifidobacterium longum group 2

Bifidobacterium longum 4-1

Group Type EXPERIMENTAL

Bifidobacterium longum

Intervention Type DIETARY_SUPPLEMENT

types of intestinal flora

Bifidobacterium longum group 3

Bifidobacterium longum gs

Group Type EXPERIMENTAL

Bifidobacterium longum

Intervention Type DIETARY_SUPPLEMENT

types of intestinal flora

Interventions

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Bifidobacterium longum

types of intestinal flora

Intervention Type DIETARY_SUPPLEMENT

A placebo made of starch

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangnan University

OTHER

Sponsor Role collaborator

Wuxi People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kan Hong, doctor

Role: STUDY_DIRECTOR

Wuxi People's hospitial

Central Contacts

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Kan Hong, doctor

Role: CONTACT

13358119885

Other Identifiers

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Z202002

Identifier Type: -

Identifier Source: org_study_id

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