RecruitingNot ApplicableNCT06968299

Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological

Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological Outcomes: An Open-label Trial


Sponsor

SunWay Biotech Co., LTD.

Enrollment

50 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria9

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTExoBDNF 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.


Locations(1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06968299


Related Trials