Status:
RECRUITING
Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological
Lead Sponsor:
SunWay Biotech Co., LTD.
Conditions:
Cognitive Functions Perceptual Disturbances
Cognitive Function Abnormal
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06968299
Start Date
May 20 2025
End Date
December 30 2025
Last Update
November 24 2025
Active Locations (1)
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1
Tri-Service General Hospital, National Defense Medical Center
Taipei, Taiwan