ExoBDNF probiotic to help thinking, sleep, and mood
Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological Outcomes: An Open-label Trial
This study will test whether taking one daily capsule of ExoBDNF probiotic for 8 weeks can help adults 18+ improve cognition, sleep quality, or mood symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SunWay Biotech Co., LTD. Industry-sponsored |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06968299 on ClinicalTrials.gov |
What this trial studies
This open-label, single-group pre/post-test study will enroll about 30 adults who will take a capsule containing 1 x 10^10 CFU of Pediococcus acidilactici ExoBDNF once daily for 8 weeks. Cognitive function, subjective cognitive complaints, sleep quality, and symptoms of depression/anxiety/stress will be measured at baseline and after treatment using standardized scales (MMSE, MoCA, PSQI, DASS-21, and others). Blood tests and fecal microbiome analyses will be performed before and after supplementation, and participants will keep a daily diary of product intake, diet, bowel habits, and any symptoms. The protocol requires participants to maintain a regular lifestyle during the intervention to limit other influences on outcomes.
Who should consider this trial
Good fit: Ideal candidates are mentally clear adults aged 18 or older who can attend in-person visits and who are seeking to improve mild cognitive, sleep, or psychological complaints and can comply with daily supplement use.
Not a fit: People with major medical conditions (severe heart, liver, kidney disease), recent brain surgery or severe brain injury, certain gastrointestinal diseases, pregnancy, or very high blood pressure are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ExoBDNF probiotic supplementation could modestly improve cognitive performance, sleep quality, and mood in some adults.
How similar studies have performed: Some prior probiotic studies have shown small benefits for mood and cognitive markers, but using Pediococcus acidilactici that delivers ExoBDNF is a relatively novel approach with limited human data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei
- Tri-Service General Hospital, National Defense Medical Center — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hsin-An Chang, MD — Director, Child and Adolescent Psychiatry, Department of Psychiatry
- Study coordinator: Sean Lin
- Email: sean.lin@sunway.cc
- Phone: 02-27929568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.