An Open Label Trial Evaluating the Efficacy of Lacticaseibacillus Paracasei PS23 on Cognition

NCT ID: NCT07168824

Last Updated: 2025-12-05

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-17

Study Completion Date

2026-12-31

Brief Summary

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This open label study aims to evaluate whether the consumption of probiotics can improve symptoms and overall quality of life in individuals experiencing cognitive decline symptoms, as well as to evaluate the effects of probiotics on blood-related biomarkers.

Detailed Description

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Lacticaseibacillus paracasei PS23 (PS23) is a specific strain of probiotic bacteria known for its potential health benefits, particularly in the context of aging and muscle health. Research suggests that it may improve cognitive function, reduce age-related muscle loss, and modulate the gut microbiota. Probiotic supplements like PS23 are being explored as potential therapeutic agents for age-related cognitive deficits. A prior study showed that PS23 supplementation delayed age-related cognitive decline in mice. Additionally, PS23 has shown antidepressant-like effects and has been found to enhance physical performance and promote muscle recovery following injury.

Conditions

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Subjective Cognitive Decline (SCD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Probiotics

Lacticaseibacillus paracasei PS23 one capsule daily for 12 weeks

Group Type EXPERIMENTAL

Lacticaseibacillus paracasei

Intervention Type DIETARY_SUPPLEMENT

one capsule daily for 12 weeks

Interventions

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Lacticaseibacillus paracasei

one capsule daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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PS23

Eligibility Criteria

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Inclusion Criteria

* Adults aged 50 to 85 years who self-report experiencing signs of cognitive decline.
* No prior diagnosis of dementia or Alzheimer's disease (AD).
* Willing and able to comply with study assessments and requirements, and provide written informed consent.

Exclusion Criteria

* Use of antibiotics or probiotic powder, capsules, or tablets within the past month.
* Currently undergoing antibiotic treatment.
* Known allergy to dairy products.
* Presence of immunodeficiency or impaired immune function.
* Diagnosis of small intestinal bacterial overgrowth (SIBO).
* Determined unsuitable by the investigator, for example, initiation of any new medication or therapy during the study period, particularly those related to memory impairment or cognitive decline.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bened Biomedical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Chi-Chang Huang

OTHER

Sponsor Role lead

Responsible Party

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Chi-Chang Huang

Dean of Research and Development

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chi-Chang Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Sport University

Locations

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Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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IRB-25-061-A2

Identifier Type: -

Identifier Source: org_study_id

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