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

NCT07168824 | Enrolling By Invitation

• 1 other identifier: IRB-25-061-A2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subjective Cognitive Decline (SCD)

Keywords

Subjective Cognitive Decline; Mild cognitive impairment; probiotics; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention

  Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests that are correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance.

  baseline to 12 weeks assessed

Secondary Outcomes (12)

• Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention

  baseline to 12 weeks assessed

• Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention

  baseline to 12 weeks assessed

• Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention

  baseline to 12 weeks assessed

• Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention

  baseline to 12 weeks assessed

• Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention

  baseline to 12 weeks assessed

Study Arms (1)

Probiotics

EXPERIMENTAL

Lacticaseibacillus paracasei PS23 one capsule daily for 12 weeks

Dietary Supplement: Lacticaseibacillus paracasei

Interventions

Lacticaseibacillus paracasei DIETARY_SUPPLEMENT

one capsule daily for 12 weeks

Also known as: PS23

Probiotics

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bened Biomedical Co., Ltd.: collaborator
• Chi-Chang Huang: lead

Study Sites (1)

Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan District, 33301, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chi-Chang Huang, PhD

  National Taiwan Sport University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean of Research and Development

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

TW (1)