the Effect of Probiotics on Aging Population

NCT04911556 | Unknown DMC

• 1 other identifier: Z202002
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Debility

Keywords

intestinal flora

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

the placebo group

PLACEBO COMPARATOR

A placebo made of starch

Dietary Supplement: A placebo made of starch

Bifidobacterium longum group 1

EXPERIMENTAL

Bifidobacterium longum 274

Dietary Supplement: Bifidobacterium longum

Bifidobacterium longum group 2

EXPERIMENTAL

Bifidobacterium longum 4-1

Dietary Supplement: Bifidobacterium longum

Bifidobacterium longum group 3

EXPERIMENTAL

Bifidobacterium longum gs

Dietary Supplement: Bifidobacterium longum

Interventions

Bifidobacterium longum DIETARY_SUPPLEMENT

types of intestinal flora

Bifidobacterium longum group 1; Bifidobacterium longum group 2; Bifidobacterium longum group 3

A placebo made of starch DIETARY_SUPPLEMENT

placebo

the placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Over 65 years old
• Frail scale score above 3 points

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuxi People's Hospital: lead
• Jiangnan University: collaborator

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kan Hong, doctor

  Wuxi People's hospitial

  STUDY DIRECTOR

Central Study Contacts

Kan Hong, doctor

CONTACT

13358119885; 2898456291@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant ,care provider,investigator and outcomes Assessor are all blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group served as a control group, while the other three groups are treated with different strains of bifidobacterium longum

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 3, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share