DebilityTEOPOGPNCT04911556
the Effect of Probiotics on Aging Population
A study testing Bifidobacterium longum in people with Debility, run by Wuxi People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Debility
- What is being tested?
- Bifidobacterium longum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 65 years old
- Frail scale score above 3 points
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study for the Effect of Probiotics on Aging Population
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.
Read the 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.
- Conditions
- Debility
- Being tested
- Bifidobacterium longum, A placebo made of starch
- Keywords
- intestinal flora
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longumDietary supplement
types of intestinal flora
A placebo made of starchDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| the placebo group | Placebo comparator | A placebo made of starch Receives: Dietary Supplement: A placebo made of starch |
| Bifidobacterium longum group 1 | Experimental | Bifidobacterium longum 274 Receives: Dietary Supplement: Bifidobacterium longum |
| Bifidobacterium longum group 2 | Experimental | Bifidobacterium longum 4-1 Receives: Dietary Supplement: Bifidobacterium longum |
| Bifidobacterium longum group 3 | Experimental | Bifidobacterium longum gs Receives: Dietary Supplement: Bifidobacterium longum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DebilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group served as a control group, while the other three groups are treated with different strains of bifidobacterium longum
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangnan University
- Responsible party
- Sponsor
- Investigators
- Kan Hong, doctor, Study director, Wuxi People's hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911556
- Sponsor's protocol ID
- Z202002
- Acronym
- TEOPOGP
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Effect of Probiotics on Aging Population
- ClinicalTrials.gov ID
- NCT04911556
- Acronym / sponsor ID
- TEOPOGP / Z202002
- Conditions
- Debility
- Keywords
- intestinal flora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wuxi People's HospitalUniversity, hospital or other
- Collaborators
- Jiangnan University
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- One group served as a control group, while the other three groups are treated with different strains of bifidobacterium longum
| Arm | Type | Receives |
|---|---|---|
| the placebo group | Placebo comparator | Dietary Supplement: A placebo made of starchA placebo made of starch |
| Bifidobacterium longum group 1 | Experimental | Dietary Supplement: Bifidobacterium longumBifidobacterium longum 274 |
| Bifidobacterium longum group 2 | Experimental | Dietary Supplement: Bifidobacterium longumBifidobacterium longum 4-1 |
| Bifidobacterium longum group 3 | Experimental | Dietary Supplement: Bifidobacterium longumBifidobacterium longum gs |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Over 65 years old
- Frail scale score above 3 points
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium longumtypes of intestinal flora | Dietary supplement | Bifidobacterium longum group 1, Bifidobacterium longum group 2, Bifidobacterium longum group 3 |
| A placebo made of starchplacebo | Dietary supplement | the placebo group |
Primary outcome
Points of probiotics intervention in aging population
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kan Hong, doctor study director
Wuxi People's hospitial
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum in people with Debility, run by Wuxi People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kan Hong, doctor (13358119885, 2898456291@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Points of probiotics intervention in aging population (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.