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

NCT06968299 | Recruiting

• 1 other identifier: 25-ExoBDNF-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Functions Perceptual Disturbances; Cognitive Function Abnormal; Sleep; Psychological

Keywords

Probiotics; ExoBDNF; Cognitive functions

Outcome Measures

Primary Outcomes (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).

  8 weeks

Secondary Outcomes (5)

• Computerized cognitive test-Go/No go

  8 weeks

• Computerized cognitive test-Task-switching

  8 weeks

• Computerized cognitive test-Working memory

  8 weeks

• Depression Anxiety Stress Scale DASS-21

  8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  8 weeks

Study Arms (1)

ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules

EXPERIMENTAL

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

Interventions

ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules DIETARY_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.

ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SunWay Biotech Co., LTD.: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, Taiwan

RECRUITING

Related Publications (21)

• Lequesne M, Cassan P, Nallet J, Ryckewaert A, de Seze S. [Vertebral hyperostosis and diabetes mellitus]. Rev Rhum Mal Osteoartic. 1970 Apr;37(4):281-6. No abstract available. French.

  PMID: 5448694 RESULT

• 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.

  PMID: 35044793 RESULT

• 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.

  PMID: 29800787 RESULT

• 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.

  PMID: 26342761 RESULT

• 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.

  PMID: 30379617 RESULT

• 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.

  PMID: 30646475 RESULT

• 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.

  PMID: 33004079 RESULT

• 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.

  PMID: 29957766 RESULT

• 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.

  PMID: 24997031 RESULT

• 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.

  PMID: 25974299 RESULT

• 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.

  PMID: 25440054 RESULT

• 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.

  PMID: 36629438 RESULT

• 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.

  PMID: 36990042 RESULT

• 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.

  PMID: 30882244 RESULT

• 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.

  PMID: 30569089 RESULT

• Adolphe M, Sawayama M, Maurel D, Delmas A, Oudeyer PY, Sauzeon H. An Open-Source Cognitive Test Battery to Assess Human Attention and Memory. Front Psychol. 2022 Jun 10;13:880375. doi: 10.3389/fpsyg.2022.880375. eCollection 2022.

  PMID: 35756204 RESULT

• Yen YC, Chiu NY, Hwang TJ, Su TP, Yang YK, Chen CS, Li CT, Su KP, Lai TJ, Chang CM. A Multi-Center Study for the Development of the Taiwan Cognition Questionnaire (TCQ) in Major Depressive Disorder. J Pers Med. 2022 Feb 26;12(3):359. doi: 10.3390/jpm12030359.

  PMID: 35330360 RESULT

• Tsai CL, Chou KH, Lee PL, Liang CS, Kuo CY, Lin GY, Lin YK, Hsu YC, Ko CA, Yang FC, Lin CP. Shared alterations in hippocampal structural covariance in subjective cognitive decline and migraine. Front Aging Neurosci. 2023 Jun 20;15:1191991. doi: 10.3389/fnagi.2023.1191991. eCollection 2023.

  PMID: 37409010 RESULT

• de Oliveira BH, Lins EF, Kunde NF, Salgado ASI, Martins LM, Bobinski F, Vieira WF, Cassano P, Quialheiro A, Martins DF. Transcranial photobiomodulation increases cognition and serum BDNF levels in adults over 50 years: A randomized, double-blind, placebo-controlled trial. J Photochem Photobiol B. 2024 Nov;260:113041. doi: 10.1016/j.jphotobiol.2024.113041. Epub 2024 Oct 5.

  PMID: 39423445 RESULT

• Nilsson P, Saito T, Saido TC. New mouse model of Alzheimer's. ACS Chem Neurosci. 2014 Jul 16;5(7):499-502. doi: 10.1021/cn500105p. Epub 2014 May 22.

  PMID: 24852598 RESULT

• Nair AB, Jacob S. A simple practice guide for dose conversion between animals and human. J Basic Clin Pharm. 2016 Mar;7(2):27-31. doi: 10.4103/0976-0105.177703.

  PMID: 27057123 RESULT

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Hsin-An Chang, MD

  Director, Child and Adolescent Psychiatry, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Lin

CONTACT

02-27929568; sean.lin@sunway.cc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 20, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)