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the Effect of Probiotics on Aging Population (TEOPOGP)

Primary Purpose

Debility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bifidobacterium longum
A placebo made of starch
Sponsored by
Wuxi People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Debility focused on measuring intestinal flora

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    the placebo group

    Bifidobacterium longum group 1

    Bifidobacterium longum group 2

    Bifidobacterium longum group 3

    Arm Description

    A placebo made of starch

    Bifidobacterium longum 274

    Bifidobacterium longum 4-1

    Bifidobacterium longum gs

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2021
    Last Updated
    June 2, 2021
    Sponsor
    Wuxi People's Hospital
    Collaborators
    Jiangnan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04911556
    Brief Title
    the Effect of Probiotics on Aging Population
    Acronym
    TEOPOGP
    Official Title
    Study for the Effect of Probiotics on Aging Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wuxi People's Hospital
    Collaborators
    Jiangnan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Debility
    Keywords
    intestinal flora

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One group served as a control group, while the other three groups are treated with different strains of bifidobacterium longum
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Participant ,care provider,investigator and outcomes Assessor are all blind.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    the placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    A placebo made of starch
    Arm Title
    Bifidobacterium longum group 1
    Arm Type
    Experimental
    Arm Description
    Bifidobacterium longum 274
    Arm Title
    Bifidobacterium longum group 2
    Arm Type
    Experimental
    Arm Description
    Bifidobacterium longum 4-1
    Arm Title
    Bifidobacterium longum group 3
    Arm Type
    Experimental
    Arm Description
    Bifidobacterium longum gs
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Bifidobacterium longum
    Intervention Description
    types of intestinal flora
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    A placebo made of starch
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    Points of probiotics intervention in aging population
    Description
    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.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Over 65 years old Frail scale score above 3 points Exclusion Criteria: Severe impairment of liver and kidney function The tumor is advanced and life expectancy is less than 2 years Severe cognitive impairment and inability to cooperate Unable to give informed consent Have participated in other study before
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kan Hong, doctor
    Phone
    13358119885
    Email
    2898456291@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kan Hong, doctor
    Organizational Affiliation
    Wuxi People's hospitial
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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