Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological
NCT ID: NCT06968299
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-05-20
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who agree to participate in this trial and voluntarily sign the trial consent form.
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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SunWay Biotech Co., LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Hsin-An Chang, MD
Role: PRINCIPAL_INVESTIGATOR
Director, Child and Adolescent Psychiatry, Department of Psychiatry
Locations
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Tri-Service General Hospital, National Defense Medical Center
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ellie LAI, master
Role: primary
References
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Other Identifiers
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25-ExoBDNF-1
Identifier Type: -
Identifier Source: org_study_id
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