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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Lin | Contact | 02-27929568 | 612 | sean.lin@sunway.cc |
| Name | Affiliation | Role |
|---|---|---|
| Hsin-An Chang, MD | Director, Child and Adolescent Psychiatry, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital, National Defense Medical Center | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28579767 | Result | 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. | |
| 35044793 | 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. |
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|
| 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. |
| 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 29800787 | 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. |
| 26342761 | 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. |
| 30379617 | 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. |
| 30646475 | 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. |
| 33004079 | 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. |
| 29957766 | 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. |
| 24997031 | 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. |
| 25974299 | 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. |
| 25440054 | 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. |
| 36629438 | 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. |
| 36990042 | 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. |
| 30882244 | 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. |
| 30569089 | 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. |
| 35756204 | 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. |
| 35330360 | 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. |
| 37409010 | 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. |
| 39423445 | 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. |
| 24852598 | 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. |
| 27057123 | 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. |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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