Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological

November 18, 2025 updated by: SunWay Biotech Co., LTD.

Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological Outcomes: An Open-label Trial

This open-label, single-group, pre/post-test clinical study was conducted to investigate whether ExoBDNF probiotic supplementation could improve cognitive ability. It is expected that 40 subjects aged 18 years and above will be recruited, with a target of 30 cases, to take ExoBDNF probiotics for a total of 8 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pre-test and post-test were conducted at week 0 and week 9, respectively. The test items included Cognitive Test Battery, SCD-Q Subjective Cognitive Decline Questionnaire, TCQ Cognitive Function Scale, MMSE Mini-Mental Scale, MoCA Montreal Cognitive Assessment Scale, PSQI Pittsburgh Sleep Quality Scale and DASS-21 Depression, Anxiety and Stress Scale, as well as blood biochemical examination and fecal intestinal flora analysis. The subjects were asked to take a capsule containing 1 x 1010 CFU of ExoBDNF probiotics once daily.

Subjects are required to maintain a regular lifestyle. After starting the diet, subjects filled out a daily diary that included questions about study product intake, other food intake, bowel movement frequency, stool quality (consistency and color), any medications received, and any unpleasant symptoms such as diarrhea, constipation, vomiting, flatulence, and discomfort. It is expected that this project will help clarify whether supplementation with Pediococcus acidilactici ExoBDNF can help improve cognitive ability, sleep or mental health.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Tri-Service General Hospital, National Defense Medical Center
        • Contact:
          • Ellie LAI, master
          • Phone Number: 0287924955
        • Principal Investigator:
          • Hsin-An Chang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects must be volunteers who are 18 years of age or older, mentally clear and able to communicate.
  2. Subjects who agree to participate in this trial and voluntarily sign the trial consent form.

Exclusion Criteria:

  1. Subjects who are expected to be or have been confirmed to be pregnant (medical history).
  2. Subjects with gallbladder disease, gastrointestinal disease, gout, porphyria, or a history of gastric weight control surgery.
  3. Subjects with high blood pressure (≥160/100 mmHg after resting for 10 minutes) or taking diuretics.
  4. Subjects with heart disease, hepatorenal insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumors, or any other disease that may affect the results of the study.
  5. Subjects with severe hearing or visual impairment that makes it impossible to perform examinations and assessments.
  6. Subjects with any history of brain surgery, penetrating, neurovascular, infectious or other severe brain injury, epilepsy or other major neurological abnormalities, such as traumatic brain injury with loss of consciousness for more than 24 hours, or memory loss after head trauma for more than 7 days were excluded.
  7. Subjects with intellectual disabilities.
  8. Subjects who had consumed probiotics or were expected to consume probiotics within 2 weeks before the screening visit.
  9. Subjects who had participated in or were expected to participate in clinical trials within 4 weeks before the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules
ExoBDNF is the product name of SWP-CGPA01 Pediococcus acidilactici, which is listed as a food-usable strain in Taiwan, China, Europe and the United States. The strain has been deposited in the National Collection of Industrial Food and Marine Bacteria (NCIMB) in the United Kingdom, and the strain number is NCIMB 44102. 1.0 x 1010 CFU SWP-CGPA01 freeze-dried powder (production and development: Morning Blossom Biotechnology Co., Ltd., Taipei, Taiwan), corn starch, crystalline cellulose and excipients in plant capsules.
Dietary supplement: ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules
Product ingredients: microcrystalline cellulose, corn starch, SWP-CGPA01 Pediococcus acidilactici powder (1.0 x 10^10 CFU); Capsule shell composition: HPMC (hydroxypropyl methylcellulose), pure water, titanium dioxide, gelatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Cognitive Decline Questionnaire (SCD-Q) scale
Time Frame: 8 weeks
To compare whether there is a statistically significant difference in the Subjective Cognitive Decline Questionnaire (SCD-Q) scale scores between the trial group and the placebo group after taking the probiotics for 8 weeks compared with the values 8 weeks ago (baseline).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computerized cognitive test-Go/No go
Time Frame: 8 weeks
Mainly used to assess concentration, reaction and memory, this task is used to measure the brain's ability to distinguish relevant and irrelevant information. The task requires participants to pay attention to the prompt and judge whether the subsequent stimulus is the target.
8 weeks
Computerized cognitive test-Task-switching
Time Frame: 8 weeks
Mainly used to assess the brain's task switching ability, the task switching task is used to measure the flexibility of selective attention. The task requires participants to switch their attention between judging the cardinality of even numbers or the size of numbers.
8 weeks
Computerized cognitive test-Working memory
Time Frame: 8 weeks
Mainly used to assess memory, this working memory task refers to the spatial span task (Corsi block tapping task), which is used to measure spatial short-term memory capacity.
8 weeks
Depression Anxiety Stress Scale DASS-21
Time Frame: 8 weeks
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 8 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-assessment questionnaire that assesses sleep quality and sleep disturbances over a one-month period.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SunWay Biotech Co., LTD.

Investigators

  • Principal Investigator: Hsin-An Chang, MD, Director, Child and Adolescent Psychiatry, Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

May 5, 2025

First Submitted That Met QC Criteria

May 5, 2025

First Posted (Actual)

May 13, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-ExoBDNF-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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