NCT06968299 Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological
| NCT ID | NCT06968299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SunWay Biotech Co., LTD. |
| Condition | Cognitive Functions Perceptual Disturbances |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-05-20 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must be volunteers who are 18 years of age or older, mentally clear and able to communicate. 2. Subjects who agree to participate in this trial and voluntarily sign the trial consent form. Exclusion Criteria: 1. Subjects who are expected to be or have been confirmed to be pregnant (medical history). 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.
Contact & Investigator
Hsin-An Chang, MD
PRINCIPAL INVESTIGATOR
Director, Child and Adolescent Psychiatry, Department of Psychiatry
Frequently Asked Questions
Who can join the NCT06968299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cognitive Functions Perceptual Disturbances. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06968299 currently recruiting?
Yes, NCT06968299 is actively recruiting participants. Contact the research team at sean.lin@sunway.cc for enrollment information.
Where is the NCT06968299 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06968299 clinical trial?
NCT06968299 is sponsored by SunWay Biotech Co., LTD.. The principal investigator is Hsin-An Chang, MD at Director, Child and Adolescent Psychiatry, Department of Psychiatry. The trial plans to enroll 50 participants.