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Cognitive Functions Perceptual DisturbancesNCT06968299

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

A study testing ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules in people with Cognitive Functions Perceptual Disturbances and Cognitive Function Abnormal, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTaiwan
Study dates
20 May 2025to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Subjects who are expected to be or have been confirmed to be pregnant (medical history).
  • Subjects with gallbladder disease, gastrointestinal disease, gout, porphyria, or a history of gastric weight control surgery.
  • Subjects with high blood pressure (≥160/100 mmHg after resting for 10 minutes) or taking diuretics.
  • 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.
  • Subjects with severe hearing or visual impairment that makes it impossible to perform examinations and assessments.
  • 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.
Show all 9Show fewer
  • Subjects with intellectual disabilities.
  • Subjects who had consumed probiotics or were expected to consume probiotics within 2 weeks before the screening visit.
  • Subjects who had participated in or were expected to participate in clinical trials within 4 weeks before the screening visit.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • Tri-Service General Hospital, National Defense Medical Center

    Taipei

    Ellie LAI, master, 0287924955

    Hsin-An Chang, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules
Keywords
Probiotics, ExoBDNF, Cognitive functions
Medical subject headings
Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)CapsulesDietary supplement

    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.

Study groups in NCT06968299
Study groupRoleWhat they receive
ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)CapsulesExperimentalExoBDNF 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.
Receives: Dietary Supplement: ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Cognitive Decline Questionnaire (SCD-Q) scale

    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).

    Measured: 8 weeks

Secondary outcomes (5)
  1. Computerized cognitive test-Go/No go

    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.

    Measured: 8 weeks

  2. Computerized cognitive test-Task-switching

    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.

    Measured: 8 weeks

  3. Computerized cognitive test-Working memory

    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.

    Measured: 8 weeks

  4. Depression Anxiety Stress Scale DASS-21

    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.

    Measured: 8 weeks

  5. Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-assessment questionnaire that assesses sleep quality and sleep disturbances over a one-month period.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start20 May 2025
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06968299
Sponsor's protocol ID
25-ExoBDNF-1
Status last verified
Nov 2025
First submitted
5 May 2025
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Klimova B, Valis M, Kuca K. Cognitive decline in normal aging and its prevention: a review on non-pharmacological lifestyle strategies. Clin Interv Aging. 2017 May 25;12:903-910. doi: 10.2147/CIA.S132963. eCollection 2017.

    PubMed 28579767
  • Erickson KI, Donofry SD, Sewell KR, Brown BM, Stillman CM. Cognitive Aging and the Promise of Physical Activity. Annu Rev Clin Psychol. 2022 May 9;18:417-442. doi: 10.1146/annurev-clinpsy-072720-014213. Epub 2022 Jan 19.

    PubMed 35044793
  • O'Donoghue MC, Murphy SE, Zamboni G, Nobre AC, Mackay CE. APOE genotype and cognition in healthy individuals at risk of Alzheimer's disease: A review. Cortex. 2018 Jul;104:103-123. doi: 10.1016/j.cortex.2018.03.025. Epub 2018 Mar 30.

    PubMed 29800787
  • Shakersain B, Santoni G, Larsson SC, Faxen-Irving G, Fastbom J, Fratiglioni L, Xu W. Prudent diet may attenuate the adverse effects of Western diet on cognitive decline. Alzheimers Dement. 2016 Feb;12(2):100-109. doi: 10.1016/j.jalz.2015.08.002. Epub 2015 Sep 3.

    PubMed 26342761
  • Schneider S, Wright CM, Heuckeroth RO. Unexpected Roles for the Second Brain: Enteric Nervous System as Master Regulator of Bowel Function. Annu Rev Physiol. 2019 Feb 10;81:235-259. doi: 10.1146/annurev-physiol-021317-121515. Epub 2018 Oct 31.

    PubMed 30379617
  • Kowalski K, Mulak A. Brain-Gut-Microbiota Axis in Alzheimer's Disease. J Neurogastroenterol Motil. 2019 Jan 31;25(1):48-60. doi: 10.5056/jnm18087.

    PubMed 30646475
  • D'Amato A, Di Cesare Mannelli L, Lucarini E, Man AL, Le Gall G, Branca JJV, Ghelardini C, Amedei A, Bertelli E, Regoli M, Pacini A, Luciani G, Gallina P, Altera A, Narbad A, Gulisano M, Hoyles L, Vauzour D, Nicoletti C. Faecal microbiota transplant from aged donor mice affects spatial learning and memory via modulating hippocampal synaptic plasticity- and neurotransmission-related proteins in young recipients. Microbiome. 2020 Oct 1;8(1):140. doi: 10.1186/s40168-020-00914-w.

    PubMed 33004079
  • Dominguez LJ, Barbagallo M. Nutritional prevention of cognitive decline and dementia. Acta Biomed. 2018 Jun 7;89(2):276-290. doi: 10.23750/abm.v89i2.7401.

    PubMed 29957766
  • Forsythe P, Bienenstock J, Kunze WA. Vagal pathways for microbiome-brain-gut axis communication. Adv Exp Med Biol. 2014;817:115-33. doi: 10.1007/978-1-4939-0897-4_5.

    PubMed 24997031
  • Sampson TR, Mazmanian SK. Control of brain development, function, and behavior by the microbiome. Cell Host Microbe. 2015 May 13;17(5):565-76. doi: 10.1016/j.chom.2015.04.011.

    PubMed 25974299
  • Sharon G, Garg N, Debelius J, Knight R, Dorrestein PC, Mazmanian SK. Specialized metabolites from the microbiome in health and disease. Cell Metab. 2014 Nov 4;20(5):719-730. doi: 10.1016/j.cmet.2014.10.016. Epub 2014 Nov 4.

    PubMed 25440054
  • Liu N, Yang D, Sun J, Li Y. Probiotic supplements are effective in people with cognitive impairment: a meta-analysis of randomized controlled trials. Nutr Rev. 2023 Aug 10;81(9):1091-1104. doi: 10.1093/nutrit/nuac113.

    PubMed 36629438
  • Fei Y, Wang R, Lu J, Peng S, Yang S, Wang Y, Zheng K, Li R, Lin L, Li M. Probiotic intervention benefits multiple neural behaviors in older adults with mild cognitive impairment. Geriatr Nurs. 2023 May-Jun;51:167-175. doi: 10.1016/j.gerinurse.2023.03.006. Epub 2023 Mar 28.

    PubMed 36990042
  • Chong HX, Yusoff NAA, Hor YY, Lew LC, Jaafar MH, Choi SB, Yusoff MSB, Wahid N, Abdullah MFIL, Zakaria N, Ong KL, Park YH, Liong MT. Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study. Benef Microbes. 2019 Apr 19;10(4):355-373. doi: 10.3920/BM2018.0135. Epub 2019 Mar 18.

    PubMed 30882244
  • Kobayashi Y, Kinoshita T, Matsumoto A, Yoshino K, Saito I, Xiao JZ. Bifidobacterium Breve A1 Supplementation Improved Cognitive Decline in Older Adults with Mild Cognitive Impairment: An Open-Label, Single-Arm Study. J Prev Alzheimers Dis. 2019;6(1):70-75. doi: 10.14283/jpad.2018.32.

    PubMed 30569089

Questions about this trial

What is this clinical trial studying?

A study testing ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules in people with Cognitive Functions Perceptual Disturbances and Cognitive Function Abnormal, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.

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 9 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sean Lin (02-27929568 ext. 612, sean.lin@sunway.cc), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Cognitive Decline Questionnaire (SCD-Q) scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06968299, which also lists 21 linked publications.

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 24 Nov 2025.

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